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📍Location: Sheffield, England, United Kingdom | 🔄Self-Employed | ⏰ Flexibility to manage your own calendar | 🤝In-Person Counselling services | 💼Own professional consulting premises Are you a qualified mental health professional looking to make a meaningful impact while enjoying flexible working arrangements? 🚀 Why Choose TELUS Health? • Comprehensive Support - Thorough induction training with dedicated Team Managers, • Professional Growth - Diverse case exposure and enhanced short-term counselling expertise, • Flexibility - Full control over referral acceptance and scheduling, • Technology- Access to our intuitive Provider Hub platform, • Community - Strong peer relationships and ongoing management support, • Development - Regular audit feedback and free CPD Learning Line events, • Insights - Customer satisfaction data to inform your practice 🎯 What You'll Do: • Manage online referrals with prompt response times, • Provide short-term, solution-focused counselling (3-12 sessions), • Connect with diverse clients facing varied workplace and personal challenges, • Maintain comprehensive case documentation and feedback, • Collaborate with our Provider Services team on risk management 📋Essential Requirements: • Accreditation: BACP/UKCP/COSCA/BPS/NCS/BABCP or equivalent, • Alternative: Diploma-level qualification + 3 years post-qualification experience + 450+ counselling hours, • Approach: Experience in short-term, solution-focused therapeutic models, • Supervision: Regular professional clinical supervision arrangements should be in place, • Insurance: Professional indemnity (minimum £1,000,000), • Compliance: ICO registration as Data Controller 🎓 Ideal Experience: • Previous EAP experience preferred but not essential, • Assessment and support planning expertise, • Short-term counselling interventions with workplace focus, • Understanding of organizational dynamics and work-life challenges, • Knowledge of local therapeutic resources and referral pathways, • IT proficiency (Microsoft Office, email, online systems)

We are working closely with an Oxford headquartered medical imaging company, looking to revolutionise the 3D x-ray market with at point-of-use technology. They are growing rapidly across UK, Europe and in the US. Currently searching for a Clinical Product Specialist. The role would be responsible for the clinical promotion and ensuring customer satisfaction of the clients Medical and Veterinary Systems. The team are looking for someone to utilise their clinical knowledge base, training expertise and commercial skills to promote and educate medical and veterinary professionals on the clients unique tomosynthesis imaging technologies. Clinical Product Specialist - Radiology Salary: Up to £70,000 + Car Allowance + Comprehensive Benefits Location: Remote - Covering UK territory Responsibilities: Product Sales Support • Promote excellent relationships with customers to ensure product and market needs are well understood and providing support to the sales team in commercial negotiations, • Contribute to the creation of compelling product marketing material (White papers, presentations), • Contribute to the completion of Technical Sales Responses, • Provide training internally and to distributors on the clients DT Medical and Veterinary systems, • Manage and Collect high quality image data to promote key system benefits Training/Applications Support • Deliver engaging training sessions to ensure high levels of customer satisfaction, • Collaborate with Service and R&D to efficiently and effectively resolve customer issues, • Deliver engaging product demonstrations to promote the benefits of the clients Medical and Vet Systems Product Development • Collate and share customer feedback to enhance future system development, • Support clinical trials and studies in conjunction with the R&D team and external clinical partners, • General/Other, • Travel to customer sites in the UK and overseas as required, • Maintain a safe working environment and follow all protocols to ensure compliance with company quality procedures and regulatory standards Requirements Skills & Qualifications • Educated to degree level in Radiography, • Current HCPC registration, • Core Radiography knowledge, and image interpretation, • An understanding of learning styles to meet customer needs, • Ability to work independently and to be self-motivated, • Problem solving nature, being ability to work through challenges under pressure, • Ability to react to changing working requirements, • Highly effective presenters; able to use Powerpoint to create impactful presentations, • Ability to communicate on a broad level within the organisation and customer environment, • Detail focus with the tenacity to see tasks through to their successful completion Experience • Experience of product support within the radiology domain, • Delivering impactful Product demonstrations, • Delivering Applications Training in a Clinical Environment, • Development of Training Material, • Successful track record of maintaining high customer satisfaction, • Providing Product Management/Development with concise and effective feedback on image quality and system functionality improvements, • Successful management of customer satisfaction challenges

Job title: EPR Solutions Architect Client: HealthTech Salary: £65,000-£75,000 + Bonus Location: Remote Skills: EPR, Solutions Architecture, Design, Processes, Enablement, Integration The role: My client are looking for an EPR Solutions Architect to join their team. You will stem from an EPR background and have strong design experience around Solution delivery. Responsibilities: • Designing workflows and programmes for EPR delivery, • Detailed documentation of solutions, • Working closely with both clinical and technical staff, • Designing the look and feel of product implementations, • Defining processes, scope and timelines for data migration, • Involved in data quality and reporting Experience required: • Experienced in Solutions Architecture and Design around EPR solutions, • Excellent documentation experience, • Deep clinical knowledge, • Experience with Integration Engines such as Rhapsody / Blue Prism etc. highly desirable Please apply ASAP for more information.

A large global organisation are looking for a Data & AI Program Lead who would be responsible for driving the vision, strategy and execution of data, analytics and AI. This will be an initial 6 - 12 months+ contract with the opportunity for multiple extensions. The role can be worked 100% remotely from the UK. Key Skills/Responsibilities: • Define and maintain the Data & AI program strategy aligned with business and digital transformation objectives., • Build and manage a multi-year roadmap covering data platforms, advanced analytics, machine learning, and GenAI applications., • Identify high-value business use cases in areas such as marketing, R&D, medical affairs, quality, manufacturing, and supply chain., • 7–12+ years of experience in data, analytics, AI, or digital transformation roles., • Proven track record leading complex data/AI programs in regulated environments., • Strong understanding of data architecture, ML/AI technologies, and cloud platforms (e.g., AWS, Azure, GCP)., • Experience working with cross-functional teams in commercial, R&D, medical, or supply chain contexts., • Excellent communication, stakeholder management, and program governance skills., • Knowledge of Generative AI, LLM integration, prompt engineering, and responsible AI frameworks., • Familiarity with GxP systems, clinical data standards, PV requirements, and regulatory submissions.

The EPR Forms Developer is responsible for designing, building, testing, and maintaining digital clinical forms, workflows, and documentation components within the organisation’s Electronic Patient Record (EPR) system. The role supports clinical and operational teams in digitising paper processes, improving data quality, and enabling safe, efficient care. The postholder works closely with clinical stakeholders, analysts, and other developers to deliver robust, user-centred EPR solutions. Design and develop clinical and administrative forms within the EPR platform. Build structured data capture elements, validations, conditional logic, and decision support rules. Configure workflows, templates, documentation tools, and UI components to support clinical pathways. Ensure developments follow trust governance, build standards, and coding conventions.

Numi are partnered with an early-stage HealthTech company building the next generation of conversational AI for the medical field. Their platform allows clinicians to create controllable, customized AI assistants that automate workflows and support clinical decision-making. While many tools exist for general transcription, we are solving the "last mile" problem in healthcare: enabling doctors and nurses to build their own deterministic, safe agents using natural language. The Engineering Challenge We are building a mission-critical platform where safety, latency, and correctness must coexist in a chaotic real-world environment. Our core technical hurdles include: • Ultra-Low Latency Voice: delivering sub-2-second response times across full duplex audio while handling "barge-ins" (interruptions) and natural turn-taking in noisy environments., • User-Defined Agent Logic: Creating a "no-code" engine where users can verbally define workflows and guardrails that the system executes deterministically., • Hierarchical & Auditable RAG: Routing queries through complex layers of patient history, clinical guidelines, and organizational policies with full traceability., • Resilient Orchestration: Managing long-running conversation states, tool usage, and concurrency control to ensure reliability even if external EHR or telephony systems falter., • Safety & Compliance: Enforcing strict scope-of-practice guardrails, PHI redaction, and rapid fallback mechanisms when model confidence drops., • Continuous Improvement: A feedback loop that utilizes automated evaluators and shadow testing to safely evolve the system in production. The Role You will own the architecture and evolution of the "Central Brain" the core service that powers our AI agents. You will design multi-agent systems that reason, retrieve data, and communicate via voice and text in real time. Key Responsibilities: • End-to-End Ownership: Define the architecture, SLAs, and error handling for the core reasoning engine., • Real-Time Comms Engineering: Implement streaming voice pipelines, focusing on VAD (Voice Activity Detection), interruption handling, and SIP/WebRTC integrations., • Advanced Agent Orchestration: Build planner-executor patterns and manage shared memory across agents., • Prompt Engineering & Optimization: utilize programmatic approaches to compile and iteratively improve prompts based on evaluation metrics., • RAG Optimization: Enhance retrieval signal through hybrid search, re-ranking, and query rewriting, ensuring high context precision and recall. Must Haves: • 5+ years of backend or ML engineering experience, with a recent deep focus on LLM application layers., • Expert-level Python: Deep familiarity with FastAPI, asyncio, and pydantic., • Real-Time Experience: Proven track record building low-latency voice or text systems (experience with WebRTC, sockets, or similar streaming technologies)., • Agentic Patterns: Hands-on experience with ReAct, Chain-of-Thought (CoT), or other reasoning frameworks., • Experience with DSPy or other programmatic prompt optimizers., • Familiarity with LLM-as-a-judge evaluation setups., • Knowledge of VoIP standards (SIP, SRTP) or modern voice infrastructure (e.g., LiveKit)., • Core: Python, FastAPI, Pydantic, Asyncio., • Data: Postgres, Redis, Vector Stores., • Voice/Infra: WebRTC, SIP Gateways, Docker, Kubernetes, Terraform., • AI/Ops: OpenTelemetry, Custom Eval Frameworks.

We are seeking an experienced Integration Analyst to support the integration of a new Electronic Patient Record (EPR) system within our healthcare environment. The successful candidate will play a key role in designing, analysing, and delivering system integrations between the EPR and multiple internal and external clinical and non-clinical systems, ensuring data accuracy, reliability, and compliance with healthcare standards. Key Responsibilities • Analyse integration requirements between the EPR system and existing applications, • Work closely with clinical, operational, and technical stakeholders to gather and document integration needs., • Design and document interface specifications, data mappings, and workflows., • Support the development and configuration of integrations using standards such as HL7, FHIR, XML, JSON, and APIs., • Collaborate with integration engine teams (e.g. Mirth, Rhapsody, InterSystems, or similar)., • Perform system and integration testing, including defect management and resolution., • Support data migration and validation activities where required., • Assist with go-live planning, cutover activities, and post-implementation support., • Ensure integrations comply with information governance, data protection, and cybersecurity requirements., • Produce clear documentation, including interface control documents (ICDs) and test plans. Essential Skills & Experience • Proven experience as an Integration Analyst or similar role in healthcare IT., • Hands-on experience with EPR/EHR system integrations., • Strong understanding of healthcare messaging standards (HL7 v2/v3, FHIR)., • Experience working with APIs and integration engines., • Ability to translate business and clinical requirements into technical integration designs., • Strong analytical, problem-solving, and communication skills., • Experience working in structured project environments (Agile or Waterfall). Desirable Skills • Experience with specific EPR systems (e.g. Epic, Cerner, System C, Epic, or similar)., • Knowledge of NHS systems and interoperability standards (where applicable)., • Experience with data migration and reporting integrations., • Understanding of clinical workflows and patient data pathways.

Frontier Science Scotland (FSS) is expanding, and we are looking for motivated, dynamic and experienced individuals to join our growing organisation. If you are passionate about improving clinical research through high-quality data management, we would love to hear from you. In this role, you will: • Play a key role in ensuring the accuracy, integrity, and completeness of clinical trial data. Contribute to end-to-end data management activities, including CRF development, query management, data cleaning, database lock,., • Be part of a collaborative, supportive team where your expertise directly influences the success and credibility of clinical research., • Collaborate closely with project teams, sponsors and internal stakeholders If you are eager to work in a supportive, innovative environment, this could be the opportunity for you. the role is hybrid/fully remote and can be full time or part time. Visit to find out more.

We are seeking an experienced EPR Test Analyst to support a major integration and expansion programme across an existing Electronic Patient Record (EPR) environment. This role is focused on ensuring the safe and high-quality enhancement of current functionality, new integrations, and improved interoperability across clinical and operational systems. You will help ensure that changes and new capabilities introduced into the EPR are thoroughly tested, clinically safe, and aligned with organisational workflows. Key Responsibilities • Develop, execute, and maintain detailed test plans, scripts, and scenarios for new integrations, enhanced features, and expanded EPR modules., • Conduct functional, integration, regression, interface, and end-to-end workflow testing., • Validate interoperability across internal systems, external partners, and third-party applications., • Review change requests, requirements, and specifications to ensure they are testable and meet clinical and operational needs., • Support interface testing, including HL7/FHIR messaging, API-driven workflows, and data exchange validation., • Work collaboratively with technical, clinical, and supplier teams to understand workflows, dependencies, and impacts., • Use established tools to manage defects, track progress, and maintain clear testing documentation., • Contribute to risk assessments, quality assurance reporting, and continuous improvement in testing processes., • Provide testing support during release cycles, upgrades, and phased expansion activities. Skills & Experience Required • Proven experience as a Test Analyst within healthcare IT, ideally working on EPR integration, enhancement, or expansion projects., • Strong understanding of clinical workflows and NHS processes (or equivalent healthcare environments)., • Hands-on experience with structured testing methodologies (e.g., Agile, V-Model, ISTQB-aligned approaches)., • Experience with interface and integration testing (e.g., HL7, FHIR, APIs, middleware)., • Familiarity with test management and defect tracking tools (e.g., Jira, Azure DevOps, HP ALM)., • Strong analytical, documentation, and problem-solving skills., • Ability to communicate effectively with multidisciplinary teams, technical experts, and clinical stakeholders., • Experience with data validation or data flow troubleshooting is desirable., • ISTQB certification or similar is beneficial.

Clinical Trial Specialist – Fully Remote (4 positions) | Europe/UK Advanced Clinical is growing and we are looking to hire four Clinical Trial Specialists to join our Clinical Operations team. These roles will support an established biopharmaceutical partner through our FSP model and offer the chance to work on global clinical studies across multiple phases. This is a fully remote opportunity. About the Role As a Clinical Trial Specialist, you will work as a Coordinator, supporting moderately complex clinical studies and contributing to the successful planning, execution, and close-out of trials. You will work closely with the clinical trial team to ensure activities are conducted in accordance with GCP, SOPs, and regulatory standards. Key Responsibilities • Support activities for Phase 1–4 studies from feasibility and start-up through close-out, • Manage and track essential study and site documentation, ensuring completeness and TMF compliance., • Assist the Study Lead in preparing clinical trial documents, site materials, and study manuals., • Coordinate and document study meetings, including agenda preparation and minutes., • Support study site oversight, including monitoring report review, site performance tracking, and issue escalation, • May perform co-monitoring or ad hoc site visits with oversight, • Assist with vendor coordination, deliverables tracking, and invoice review, • Participate in data review, query resolution, deviation assessments, and safety-related activities, • Collaborate cross-functionally with internal teams, CROs, and vendors to maintain study progress, Requirements • Minimum of 2 years’ experience in clinical research (3 years preferred), ideally within pharma, biotech or CRO, • Previous experience in site monitoring or as a study coordinator is advantageous., • Strong understanding of GCP, ICH guidelines, and the clinical development process, • Experience with electronic systems such as TMF, CTMS, Veeva Vault, SharePoint, or similar, • Proficient in Word, Excel, and PowerPoint, with strong communication and organisational skills, • Bachelor’s degree in a scientific or health-related discipline (or equivalent) Why Join Advanced Clinical? This opportunity offers remote work flexibility, exposure to global trials, and the opportunity to grow within a high-performing team working closely with an innovative sponsor. You will be part of a collaborative environment where your contributions will have an impact.

Genomics Data Scientist (Bioinformatics / Biostatistics) ARCA is building a nationwide talent pool of Genomics Data Scientists with skills across bioinformatics, biostatistics, computational genomics and large-scale data analysis. We support NHS organisations, research groups and biotech partners and are looking for candidates at all levels for upcoming contract and permanent roles, starting in 2026. What You’ll Work On: • Analysis of large genomic datasets (WGS/WES, RNA-Seq, variant calling)., • Developing and maintaining bioinformatics workflows and pipelines., • Applying statistical modelling to genomic and clinical data., • Generating insights to support research, clinical decision-making and population health programmes., • Collaborating with multidisciplinary teams across science, data and clinical domains. What We’re Looking For: • Background in Bioinformatics, Biostatistics, Computational Genomics, Data Science or similar., • Experience with genomic data formats and tools, • Strong R and/or Python skills., • Understanding of statistical methods used in biological data analysis., • Clear communicator with good coding and documentation practices., • TRE/SDE/HPC experience is a bonus Join the ARCA Genomics Talent Pool Register your interest to be considered for roles across the NHS, academia, biotech and national genomics initiatives.

About SmartCo Future Health SmartCo Future Health is an award-winning consultancy shaping the future of healthcare. We bring a best-in-class team and future-focused approach; empowering customers, programmes and partners. We believe in people-centered healthcare transformation, supporting our customers with seamless delivery throughout the transformation journey, providing high quality, value and innovation. We’re proud to have built a diverse collection of exceptional people, who consistently and expertly deliver transformative technology projects to our many customers. We’re growing rapidly and have ambitious plans to continue this trajectory. We offer a highly flexible, openminded and respectful place to work, full of learning and development opportunities, supporting everyone to achieve their best. Overview of the Position Job Title: EPR Delivery Consultant Reporting to: EPR Delivery Principle Consultant Organisational Function: Consulting & Delivery Services Job Family: Consulting Services The EPR Delivery Consultant will be responsible for supporting the end-to-end delivery of Electronic Patient Record (EPR) solutions across healthcare organisations. This role encompasses configuration, testing, training, and deployment activities for leading EPR platforms such as Epic, Cerner, Allscripts, Meditech, Lorenzo, and similar systems. Responsibilities One of the following: • Configure EPR modules (clinical, administrative, and operational) to meet workflow requirements, • Develop and execute EPR testing scripts, including UAT, SIT and regression, • Develop and execute EPR training plans including materials, QRGs and e-learning content, • Support data migration by extracting, transforming and loading data. Qualifications • EPR Expertise is essential for this hire, • Strong understanding of NHS workflows and clinical processes, • Strong verbal, written, and organisational skills

About Freyr Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance. Why Freyr? At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint , we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services. Join Our Team: If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr. Together, we can shape the future of regulatory solutions. 📢 To Apply: Please apply to this job post or you can visit our Careers page for more openings Visit our Careers page at () to explore current job openings and submit your application. Don't miss this chance to be a part of Freyr's expansion and make your mark in the world of regulatory services. Let's redefine regulatory excellence together! Position : Medical Writer - Clinical Location : United Kingdom Duration : 1 year fixed term employment Job Description: • Comprehensive QC review of clinical sections of regulatory documents, including but not limited to, IBs, Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologic License Applications (BLAs), Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs), briefing packages for regulatory agency meetings/advice, including verification of all references and source data, to achieve the highest quality from a technical, regulatory, and compliance perspective. Verify internal consistency within a document and across related documents., • Comprehensive content QC of clinical data/reports., • Documentation of QC findings in the appropriate manner/ tool, • Content QC activity is applicable for all therapeutic areas, development phases, modalities and geographic regions., • Checking of data presented in text and tables/figures against source documents for consistency and accuracy., • Verification of the data/content (100%) including text, tables, and figure as per the source documents., • Review for grammar, punctuation, spelling and compliance with specified styles/standards., • Maintenance of the QC records and checklists.

We are expanding our team here at Rayner! Reporting into the Global Director, Clinical Research, the Clinical Operations Manager will be a truly collaborative professional, working closely with KOLs, investigators, and ophthalmic research organizations to provide scientific advice to both internal and external stakeholders. What You'll Be Doing: Clinical Trial Management & Regulatory Compliance • Develop Strategies for Effective Clinical Data Generation, • Oversee the design, execution, and approval of global clinical and preclinical trials for ophthalmic medical devices., • Ensure adherence to ISO 14155:2020, ISO 11979:2024, MDR 2017/745, ICH GCP, 21 CFR 812, ANSI Z80.x, and national regulatory requirements., • Manage submissions to ECs and CAs (e.g., EMA, MHRA, BfArM, AEMPS)., • Ensure compliance with GDPR for data protection in clinical trials, including handling of patient data, informed consent, and data transfer regulations. Clinical Documentation & Site Training • Develop and maintain CIP, IB, ICF, CRFs, TMF, and Accountability Logs., • Provide ISO 14155:2020 training to clinical trial sites and ensure protocol adherence., • Ensure compliance with GDPR in data collection, processing, and anonymization. CRO & Vendor Oversight • Select, contract, and manage CROs or other relevant vendors, • Ensure quality control, timely reporting, and adherence to study objectives., • Coordinate trial operations, from site selection and monitoring to study closure. Data Management & Risk-Based Monitoring • Oversee data collection, validation, and analysis using EDC platforms., • Implement RBM to optimize trial efficiency and compliance., • Conduct interpretation, analysis and summary of clinical data, focusing on ophthalmic surgical postoperative outcomes. Stakeholder Collaboration & Scientific Leadership • Work closely with KOLs, investigators, and ophthalmic research organizations to provide scientific advice to both internal and external stakeholders., • Provide clinical support to internal teams (R&D, Regulatory, Quality, Marketing, etc., • Support Rayner share of Voice in scientific conferences, regulatory discussions, and advisory boards. Assist the Clinical Compliance team by providing clinical data to support registration dossiers and regulatory submissions. Marketing & Commercial Support • Collaborate with marketing, commercial teams, and field product specialists to enhance Rayner’s scientific share of voice, support tender applications, and contribute to reimbursement programs., • Trial Budgeting & Process Optimization, • Assist with budget planning, vendor contract development, and cost control., • Drive process improvements in clinical trials, leveraging digital innovations. What Experience & Skills You Will Need: • Degree in medical, natural, technical, life sciences, or health-related fields, with extensive experience in medical device or pharmaceutical research., • 3-5 years of experience in ophthalmic clinical research, including clinical trial design, execution, and regulatory compliance., • Extensive expertise in ophthalmic clinical trials and global medical device regulations (ISO 14155, MDR, FDA 21 CFR, GDPR., • Strong understanding of ophthalmic clinical methodologies, including visual acuity testing contrast sensitivity, defocus curves, and surgical postoperative outcomes., • Expertise in ophthalmic data analysis., • Demonstrated ability to interpret and communicate ophthalmic clinical data for regulatory submissions and scientific publications., • Strong project management expertise in ophthalmology clinical trials, including site selection, monitoring, and CRO/vendor management., • Ability to travel as required., • Excellent English writing and communication skills; proficiency in additional languages is an advantage., • Self-driven, accountable, and a collaborative team player, capable of working independently and cross-functionally. What We Can Offer You: • Comprehensive benefits package, • Global appreciation platform to recognise colleagues around the globe, • Fantastic opportunity to work with highly talented teams and individuals and grow with the business, • Being part of an organisation you can be proud to work for changing the lives of millions of people!

Job Title: Senior Manager, Regulatory Labelling Location: UK, Fully Remote Salary: Competitive Salary + Excellent Benefits Employee Type: Permanent As a Senior Manager, Regulatory Labelling, you will take leadership on everything related to Regulatory Labelling. This includes inputting from a regulatory labelling perspective on developing and established drug programs and being accountable for driving global labelling strategies. This is a challenging opportunity to demonstrate your knowledge in managing regulatory processes and supporting cross-functional teams with end-to-end labelling processes. Responsibilities: • Support end-to-end labelling processes including driving labelling strategies for both development programs and established drugs and oversee all operational labelling activities., • Be responsible for executing and effective quality control reviews and tracking (primarily) internally used labeling documents (Core Data Sheet, Core Patient Information Leaflet, Core Instructions for Use) and outward facing local/regional labeling (EU SmPC, EU PIL, etc) as well as container and carton labels to meet regional regulatory requirements and ensure consistency between labeling, labels and supportive documents., • Act as operational expert for the Global Labeling tracking in RIMs, ensure development and maintenance of templates, collaboration features and system upgrades., • Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading/editing skills and compiling supportive documentation., • Support labeling inspection/audit readiness activities., • Conduct international labeling operations activities to support global new product and supplemental applications to product registration, and post approval launches for impacted international markets., • Collaborate with Technical Operations team members to ensure commercial distribution, Regulatory Technology for labeling submissions, PV for safety reporting, and other functional groups. Provide labeling to Advertising and Promotion for marketing pieces, and with Commercial for website postings if needed., • Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control., • Utilize regulatory/product knowledge to provide operational support to ensure that labeling materials meet regulatory and company requirements and timelines. Skills and Experience: • University Degree in a scientific degree., • Experienced in the following, CCDS, PIL, USPI, Target label profiles., • 5+ years of experience in drug development especially in labelling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality., • Good working knowledge of key labeling regulations/guidance and past experience in label development, • The ability to research and create comparator labeling documents, • Electronic document management systems use and / or electronic submission experience, • Solid understanding of requirements for tracking of labeling updates. Understanding of label development and submission processes preferred., • Solid aptitude for use of IT systems; Regulatory Information Management System (RIMS), electronic document management system (EDMS). Ability to manage the review and approval of labeling in a document management system., • The ideal candidate should be action oriented, customer focused, ability to manage workloads and set priorities. In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams, • Fluent in English written and spoken To be considered for this position, you must be based in the following locations: UK, Spain, Germany, or Bulgaria. Please note this role does not offer sponsorship and the right candidate must hold the Full Right to Work. For more information, please contact

Clinical Research Associate (CRA) / Site Manager – Europe (UK-based) Location: Europe (UK-based with high travel to sites in Spain, Italy, Germany, France, Netherlands) Contract Type: Flexible – EOR options available Travel Requirement: High (to 5-6 sites across Europe) Overview We are seeking an experienced Clinical Research Associate (CRA) or Site Manager to manage and support the execution of clinical trials across multiple sites in Europe, including the UK, Spain, Italy, Germany, France, and Netherlands. The role will involve high travel, site management, data collection, and protocol setup across a variety of surgical settings, with a strong focus on data management and clinical operations. This is an excellent opportunity for someone with a background in clinical research, operating room (OR) settings, and medical technology with flexibility to take on a dynamic role in a fast-paced, growing environment. Key Responsibilities • Site Management & Monitoring:, • Oversee the execution and monitoring of clinical trials at 5-6 sites across Europe, including Spain, Italy, Germany, France, UK, and Netherlands., • Ensure trial compliance with GCP, regulatory guidelines, and clinical protocols., • Manage site startup activities, monitor progress, and perform regular site visits to ensure high-quality data collection and patient safety., • Conduct regular site training and follow-up visits to ensure adherence to study protocols., • Data Management:, • Oversee and ensure accurate data entry into relevant databases, including data verification and video management from sites., • Assist with the setup of clinical protocols, ensuring that all necessary materials and databases are correctly implemented and maintained., • Monitor data quality, resolve data discrepancies, and work with the data management team to ensure that clinical trial data is accurate, complete, and compliant., • Prepare and assist with data demo sessions as needed., • Clinical Research & Medical Tech Experience:, • Demonstrate knowledge of medical technology, particularly in relation to OR settings, including laparoscopic and robotic surgery., • Experience in clinical research, particularly within colorectal surgery, soft tissue, general surgery, and gynaecology., • Familiarity with laparoscopes, minimally invasive surgery techniques, and robotic surgery is essential., • No orthopaedic or catheter lab experience required., • Regulatory Compliance & Support:, • Work closely with clinical teams to ensure regulatory compliance, patient safety, and trial integrity across all study sites., • Support the preparation of required documentation, including protocol amendments and clinical trial reports., • Clinical Research Experience:, • Previous experience as a CRA, Site Manager, or similar role in clinical research and clinical trial management., • Experience working with data management, including data entry, quality control, and study setup., • Background in medical technology or clinical trials involving medical devices is a plus., • Surgical & OR Experience:, • Hands-on experience or familiarity with operating room environments, specifically in laparoscopic surgery, robotic surgery, and other minimally invasive surgical techniques., • Experience in colorectal surgery, soft tissue, general surgery, and gynaecology is highly desirable., • Language & Communication Skills:, • English proficiency required, as communication with sites across Europe will be primarily in English., • Knowledge of Japanese would be an asset but is not essential., • Flexibility & Travel:, • The role requires high travel across European sites, so flexibility is key., • This is not a super-fast process, but we are looking for someone with the right experience who can take on a high-visibility, highly flexible role., • The role will primarily involve data management, with the opportunity to demonstrate clinical tech in surgical environments., • Budget is available for the right candidate, but the timeline is not short, allowing for careful selection of the ideal candidate., • We are looking for someone who can go about the work gently, without overwhelming the sites with too much at once.

Role Title: Senior Salesforce Solution Consultant – Healthcare & Life Sciences Location: UK (Remote / Hybrid) Reports to: Delivery Director Type: Full-time, Permanent About Ignyto Ignyto is the leading Salesforce consultancy partner, helping businesses across Europe transform their operations and accelerate growth through the power of Salesforce technologies. We work hand-in-hand with Salesforce teams and customers to design, implement, and scale digital solutions that drive measurable impact. Our Values At Ignyto, we live by the following core values: • Ownership – We all take individual responsibility for our work and outcomes., • Hard Working, Constantly Excellent & Reliable – We set very high standards and deliver consistently., • Transparency & Great Communication – Open, honest, and effective communication is key to our success., • Promise & Over Deliver – We go above and beyond to exceed expectations., • Honesty, Integrity, & Respect – We build trust through ethical business practices and mutual respect. We are seeking a highly experienced Senior Salesforce Solution Consultant or Architect with deep expertise in Healthcare & Life Sciences. You will lead world-class Salesforce implementations — including Health Cloud — and own the solution from discovery through to go-live. This includes running workshops, shaping architecture, designing end-to-end solutions, and ensuring our customers receive an exceptional delivery experience with measurable business impact. You will also play a key role in pre-sales, partnering with our sales team and Salesforce Account Executives to influence decision-makers, define solution vision, and bring industry credibility into the room. This role is ideal for a strong communicator and problem-solver who combines technical excellence, industry knowledge, and consulting presence to build trust, drive transformation, and deliver referenceable success for every customer. This is a high-visibility opportunity for a senior professional who wants to make a genuine impact across strategic projects and help shape the growth of a fast-rising Salesforce partner. Key ResponsibilitiesDelivery (70%) • Lead end-to-end Salesforce solution delivery (Health Cloud, Life Sciences Cloud, Sales Cloud, Service Cloud, Experience Cloud), • Run discovery sessions, client workshops, and solution design engagements, • Produce high-quality deliverables including solution designs, data models, user stories, security and integration designs, • Align solutions to healthcare workflows and compliance requirements (GDPR, PHI/PII, audit, access control), • Provide technical leadership and support to the delivery team to ensure quality outcomes, • Manage solution risks, assumptions, dependencies, and scope boundaries to prevent overruns, • Support testing, training, deployment and post-go-live stabilisation, • Support selected strategic opportunities with discovery, demo preparation, and solution visioning, • Shape compelling architecture narratives for target customers, • Present confidently to clinical, operational, business and IT stakeholders, • Provide LOE guidance, solution fit insight, and SOW input to the sales team, • 6–10+ years of Salesforce delivery experience (Senior Consultant to Architect level), • Proven experience delivering HLS-focused solutions, • Strong understanding of healthcare or financial services workflows (e.g., referral management, care coordination, patient engagement, contact centre operations, scheduling, and integration with EHR/clinical systems), • Strong solution design and HLD documentation capability, • Excellent communication, workshop, and demo skills, • Consulting experience in a customer-facing role is essential, • Base: Competitive - Depending on experience, • Bonus: 10–15%, aligned to successful delivery and pre-sales impact, • Benefits: Training and certification budget, • Competitive salary + bonus, • Opportunity to work with top Salesforce experts across Europe, • Fast career progression within a scaling consultancy, • Exposure to high-profile Salesforce projects, • Flexible remote / hybrid environment, • Culture that rewards initiative, ownership, and excellence

The job holder will support the delivery of the Company’s key business objectives through the delivery of their key accountabilities as follows: • Design and deliver comprehensive onboarding programmes for new starters with product knowledge, clinical education, and selling skills, which accelerate time to competence., • Develop learning interventions to build advanced capability in insight led, value-based conversations using our chosen selling model., • Collaborate with regional sales leaders to provide in field support to embed skills through observation, feedback and coaching, tracking and documenting individual skill development., • Conduct skills gap analyses and create engaging and effective ongoing learning interventions both in-person, via eLearning and live virtual delivery., • Adapt learning interventions to reflect role and regional needs, different customer segments and evolving market conditions., • Measure and report on the impact of all learning interventions., • Collaborate with marketing, medical affairs, and sales leadership to develop training interventions for sales conferences and other events ensuring training materials are accurate, compliant, and up to date., • Ensure the field force is prepared to position new product launches effectively and differentiate against competitors., • Support the Head of L&D and collaborate with HR, to integrate learning with wider initiatives to support succession planning and talent development., • Ensure all training adheres to regulatory and company compliance standards., • Occasional involvement with the recruitment process for relevant field roles (e.g. developing and conducting role play exercises)., • To ensure professional knowledge and skills are kept updated by actively participating in learning opportunities and continuing ongoing professional development., • This job description and person specification is provided as a guide to the main duties and responsibilities of the post. The post-holder is required to work flexibly and to undertake such other duties as may be reasonably required. KEY COMPETENCIES Communication Excellence Listens actively and demonstrates an understanding of the views of others and communicates in a realistic and practical manner using appropriate language. Is able to convey complex ideas clearly, uses emotional intelligence to adapt style to diverse audiences and inspire confidence. Learning Design and Delivery Applies adult learning principals to design learning-based interventions using multiple formats including face to face and digital/virtual delivery and through field coaching methods. Facilitation and Coaching Creates interactive learning sessions which engage group participants of various sizes, from small groups to large audiences at internal sales conferences. Provides constructive feedback that builds confidence and capability leading to behavioural change. Creativity and Analytical Thinking Able to generate and put into practice new ideas or approaches for learning and development, commercial or organisational benefit. Always focusing on continuous improvement. Is able to understand, link and analyse data and information to identify the learning needs, develop options and support sound decision making and actions. Planning and organising Is able to organise own time effectively, creates own work schedules, prioritises, prepares in advance and sets realistic timescales. Has the ability to visualise a sequence of actions needed to achieve a specific goal and how to estimate the resources required. Takes the initiative to identify opportunities or solve problems, taking personal accountability to deal with issues that arise reactively. Able to be pro-active and think strategically to deliver results and/or avoid issues in the long term. Adaptability Adjusts plans quickly in response to new priorities within the business, responding quickly whilst maintaining excellence in standards. Strategic Alignment Ensures all training is developed to motivate others to deliver results in line with the business objectives and market opportunities. Is a visible and accessible role model who reflects company values.Provides clarity regarding KPI targets, standards and performance expectations and provides the resources and support others need to deliver. Monitors performance and takes appropriate action to tackle poor performance whilst taking accountability for delivering results themselves. Stakeholder Management Builds trusted relationships with senior stakeholders in Sales Leadership, Marketing, HR, Medical Affairs and Commercial Excellence. Influence and Credibility Has the personal presence, credibility, authority and impact to positively influence people at all levels of the business. Uses emotional intelligence to influence others to achieve positive outcomes in their areas of expertise. Gains support for ideas and motivates others to advance the objectives of the organisation and influence outcomes. Is able to present key points of an argument persuasively, negotiate and convince others. Remains calm during periods of high intensity. Resilience and Diplomacy Navigates complex relationships and competing priorities and communicates with tact and respect, ensuring alignment and collaboration without conflict. Managing and developing performance Focuses on the effectiveness of the organisation and improving business performance through influencing positive changes to people competence and capability through developing knowledge, skills, coaching and mentoring. Is able to inspire individuals to give their best to achieve a desired result and maintains effective relationships with individuals and the team as a whole, to ensure that the team is equipped to achieve objectives set according to meet the overall business need. Qualifications and Experience • CIPD or relevant qualification in teaching or adult learning would be an advantage, • Solid knowledge of the sales process with previous field sales training and coaching experience within the medical device or pharmaceutical industry., • Relevant experience within the wound care market in either sales, L&D or a training role will be an advantage., • Proven experience of coaching and developing sales representatives and delivering training programs, • Ability to adapt in a fast-paced work environment; must be a high-energy and a motivated self-starter

The opportunity The NHS is operating under sustained financial pressure, with an increasing need to deliver material, recurrent savings while maintaining service quality and patient outcomes. NHS organisations require senior commercial expertise to identify cost improvement opportunities, challenge existing contractual arrangements and secure better value from third-party spend. This Associate Director Cost Improvement (Contract Spend) role offers the opportunity to lead and deliver high-impact cost improvement activity within NHS providers. You will work closely with executive teams and stakeholders to identify opportunities, apply commercial levers and negotiate improved contractual outcomes, delivering tangible, measurable savings for the NHS. Why join Attain Attain offers a genuinely different proposition to traditional consultancies. We are a values-led organisation with a strong mix of public sector values and private sector thinking. A high proportion of our people have worked directly within the NHS, giving us real credibility with clients. Our teams work shoulder-to-shoulder with long-term NHS partners to deliver tangible savings, improve services and make a lasting impact. We are deeply people-focused, investing heavily in career development, learning and leadership, with clear opportunities to progress within our business and into senior roles leading projects, care sectors or portfolios. As a growing business, Attain offers exposure to varied, high-impact work, meaningful responsibility, and the chance to shape how we operate. We reward contribution and performance, foster a supportive and inclusive culture, and place real value on doing the right thing, for our people, our clients and the communities they serve. The role In this role you will be responsible for: • Delivering cost improvement savings within NHS providers, with a focus on contract and third-party spend, • Working at pace to deliver an agreed savings target - normally in a pressurised “turnaround” environment - with a clear Return on Investment (ROI) expectation from your individual role., • Identifying, quantifying and prioritising cost improvement opportunities, • Applying commercial levers, negotiation strategies and market insight to secure improved value for money, • Leading commercial strategies, such as, contract rationalisation / demand management / price-volume / indexation review / benchmarking, • Reviewing contracts to identify saving opportunities, commercial risk and optimisation potential, • Engaging confidently with executive leaders, including Directors of Finance and senior operational leaders, • Operating with a high degree of autonomy while contributing to wider Attain delivery teams, • Operating effectively in hybrid environments, with regular on-site presence on client sites Skills and ways of working You will demonstrate: • A strong focus on delivery of measurable savings. Taking accountability for personal savings targets and those of team members, • Confidence in commercial negotiation and influencing senior stakeholders, • Ability to analyse contracts, financial data and commercial arrangements, • Resilience and adaptability in turnaround and recovery environments, • Clear, confident communication skills, including at executive level Stakeholder engagement You will work closely with: • Clinical leaders, • Executive and senior management teams (including Directors of Finance), • Organisational stakeholders (including finance, procurement and operational colleagues) Building trust, credibility and alignment will be central to your success. The working environment The role will be in an NHS provider. The working environment is: • Fast-paced, dynamic and often pressurised, • Frequently operating in turnaround or recovery contexts, • Highly accountable, with clear expectations around ROI and impact, • Requires resilience, adaptability and pace About you Your current role You will bring: • A strong track record of delivering savings within NHS providers, • Significant experience in managing contract spend, cost improvement or commercial roles, • Confidence operating autonomously while contributing to team delivery, • Experience of influencing and negotiating; delivering better pricing, performance or improved terms, • A clear personal track record of ROI and impact, • Operating within a clear governance structure, • Ability to prioritise to maximise benefits for clients Your achievements Successful candidates will be able to evidence: • Delivery of material, quantifiable savings (in excess of £2m per annum), • Success in identifying, quantifying and prioritising cost improvement opportunities, • Ability to understand, interpret and amend commercial agreements, • Successfully analysing complex financial information to identify opportunities, • Success in challenging existing commercial arrangements, • Strong negotiation skills and delivering outcomes against demanding targets to time, • Effective Executive-level influence, engagement and reporting Your career background We are looking for candidates who have: • Significant relevant experience, • A finance and/or commercial background, • Varied experience across public and private sectors, • Proven delivery in commercial or cost improvement roles, • A strong understanding of contractual and commercial drivers Your personal attributes You will be: • Aligned to Attain’s values-led culture, • Highly accountable for your own ROI and driven by results, • Driven to make savings and improve services, • Dynamic and able to re-prioritise opportunities, • Confident and skilled negotiator, • Analytical, commercially astute and outcome-focused The benefits • Competitive salary, • Performance/profit-based annual bonus of circa 10%, • 27 days of annual leave, plus bank holidays on top, • 6% employer contribution pension scheme, • Company-paid subscription to a professional body, • Hybrid working but also opportunities to work in coworking spaces, • A suite of learning tools to support continuing professional development, • Experience a rich variety of delivery projects across different care areas At Attain our culture and company values promote a supportive and inclusive environment where our employees’ differences are nurtured to enable everyone to reach their full potential. We are committed to a culture where respect and understanding is fostered, and the diversity of people's backgrounds and circumstances are positively valued as they enable Attain to continually bring creativity and innovation to our clients work and internally. Our recruitment process reflects this commitment, focusing on skills, capabilities, and experience to ensure fairness and equity at every step.

About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: • HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib)., • HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. Overview of Role: The Clinical Trial Manager is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial. Role and Responsibilities: • Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are met, • Initiates and builds solid professional relationships with key opinion leaders and clinical site staff, • Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time, • Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data, • Proactive identification and management of study related risks, • Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements, • Responsible for reviewing and managing study related plans, processes including, • Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring, • Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met, • Reviews and approves essential document packages to enable timely site activations, • Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report, • Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates, • Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary, • Responsible for oversight on the maintenance of the TMF and completeness at the end of the study, • Perform periodic QC of the TMF, • Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs, • Ensures the study is “inspection ready” always, • Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project, • All other duties as assigned Experience, Education and Specialized Knowledge and Skills: • Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred, • 5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization, • Prior phase II and III experience required, • A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process, • Experience with budget forecasting and management, • Experience with clinical studies in oncology, • Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%), • Proven proficiency in overseeing large complex studies being managed in house and by a CRO, • Demonstrated ability to lead teams and work in a fast-paced team environment, • Experienced and enjoys building relationships with KOLs and site personnel, • Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues, • Demonstrated ability to build and deliver on patient enrollment strategies, • Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives, • Demonstrated ability to comprehend complex scientific concepts and data, • Proficient in reviewing and assessing clinical data, • Possesses excellent planning, time management & coordination skills, • Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs, • Experience in working in a small organization, • Excellent written and oral communication skills Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

We are seeking an experienced EPR Benefits Realisation Manager to lead the identification, tracking, and delivery of benefits associated with the implementation of our Electronic Patient Record (EPR) programme. This role is critical in ensuring that the EPR delivers measurable improvements in clinical outcomes, operational efficiency, staff experience, and value for money. You will work closely with clinical leaders, operational teams, digital specialists, and programme management to embed benefits realisation into programme delivery and business-as-usual operations. Key Responsibilities • Develop and maintain a comprehensive EPR Benefits Realisation Framework, aligned to organisational strategy and programme objectives, • Identify, define, and quantify clinical, operational, financial, and workforce benefits arising from the EPR programme, • Establish robust baseline measures, KPIs, and benefit metrics prior to implementation, • Track, analyse, and report benefits realisation throughout implementation and post go-live phases, • Work with clinical and operational stakeholders to ensure benefits are owned, delivered, and sustained, • Support business case development and assurance processes with evidence-based benefits modelling, • Embed benefits tracking into programme governance, reporting, and decision-making, • Identify risks to benefits realisation and develop mitigation strategies, • Support change management activities to ensure benefits are realised through adoption and optimisation, • Produce clear, concise reports for senior leaders, boards, and external stakeholders Essential Skills & Experience • Proven experience in benefits realisation management within large-scale digital or transformation programmes, • Experience working on EPR / EHR / clinical systems implementations (healthcare experience strongly preferred), • Strong understanding of programme and change management methodologies, • Ability to work with clinical, operational, and technical stakeholders at all levels, • Experience developing KPIs, dashboards, and performance metrics, • Strong analytical skills with the ability to translate data into actionable insights, • Excellent communication and stakeholder engagement skills Desirable • Experience in healthcare, NHS, or public sector digital transformation, • Knowledge of EPR systems such as Epic, Cerner, Oracle Health, or similar, • Experience supporting business cases and benefits assurance processes, • Relevant qualification in programme management, change management, or benefits management

Geographical Location: South of England Start Date: This role will not commence until April 2026 At Kimal, we’re proud of a culture shaped by Integrity, Positivity, Inclusion, and Kindness. We work collaboratively, support one another, and create an environment where colleagues can grow and contribute meaningfully. If you share these values and are passionate about enhancing patient care through clinical excellence, we would love to hear from you. About the Role We are seeking a committed Clinical Support Specialist to join our expanding Diagnostic Green (DxG) Business Unit. In this role, you will provide high-quality clinical support, education, and product guidance to customers across multiple therapy areas, with a strong focus on fluorescence-guided surgery. You will work closely with our commercial teams, offering in-theatre support, delivering training, and helping ensure the effective adoption of our technologies. This is a hands-on, customer-facing role where you will play a key part in supporting clinical best practice. Key Responsibilities • Provide in-field clinical support and respond to customer queries on products and procedures., • Deliver high-quality, in-theatre training and education to key customers and centres., • Support customer evaluations and ensure timely resolutions to clinical or technical issues., • Build strong relationships with clinicians, procurement teams, and key decision-makers., • Collaborate with the Business Unit Manager, marketing, and sales teams to drive new business., • Stay up to date with clinical guidelines, research, and emerging technologies., • Contribute to the development of customer support materials and training resources., • Complete administrative duties including field reports, forecasting, quotations, and vigilance reporting. About You Essential Experience & Knowledge • 2–3 years of experience in a healthcare, medical device, clinical support, or theatre-based role., • Strong understanding of clinical procedures as well as anatomy and physiology., • Experience within the healthcare or medical device sector, ideally with theatre exposure., • Degree in Human Biology, Life Sciences, or a related field., • Excellent communication and presentation skills., • Confident in building relationships across varied stakeholder groups., • Comfortable working in theatre settings alongside surgeons and multidisciplinary teams., • Highly organised with the ability to adapt to changing demands. Working Conditions • Home-based with significant UK travel (average 15,000–20,000 miles per year)., • Valid UK driving licence and access to a vehicle required., • Occasional evening or weekend work may be necessary., • Mix of clinical environment and hot-desk office access when needed. Why Join Kimal? This is a fantastic opportunity to be part of a supportive, values-driven organisation that contributes directly to improving patient care. You’ll have the autonomy to shape your work, access to development opportunities, and the chance to work with innovative clinical technologies. To learn how we use and protect your data, please see our Employee Privacy Policy.___

Lead the code behind clinical breakthroughs-join a CRO investing in the future of Statistical Programming. R&D Partners is seeking Senior and Principal Statistical Programmers to join a highly specialized CRO that is investing heavily in the growth of its Statistical Programming function. Please note that to be considered for this role you must have the right to work in this location. Responsibilities: • Lead/support the design, development and validation of SAS programs for statistical analysis and reporting of clinical trial data, • Collaborate closely with biostatisticians to create comprehensive analysis plans and apply appropriate statistical methods., • Perform QC checks and review statistical outputs to ensure compliance with project specifications and regulatory guidelines., • Assist in the preparation of statistical reports, presentations, and regulatory submissions to support clinical development programs., • Mentor junior programmers and contribute to team development by sharing best practices and technical knowledge. Key Skills and Requirements: • Full right to work in UK/EU, • Experience in Statistical Programming within a Pharma, Biotech, CRO, Medical Device or similar company, • Skilled communicator to Statistical Programming and Non-Statistical Programming personnel For more information, please contact George Breen. If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page. R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy. By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data -

Clinical Trial Manager – UK | Advanced Clinical (FSP Model) Oncology focused Advanced Clinical is seeking an experienced Clinical Trial Manager to join our UK-based Functional Service Provider (FSP) team. This role will support global clinical studies and requires strong operational, vendor management, and monitoring oversight experience. Responsibilities include: • Managing external vendors and CROs, • Preparing key study documents, including Monitoring Manuals, Study Operations Manuals, SDV Plans, and Laboratory Manuals, • Designing and coordinating study materials such as CRFs, patient diaries, source documents, and participation cards, • Assisting with protocol development and study reports, • Overseeing monitoring activities to ensure compliance with GCP, SOPs, and study protocols, • Providing direction and support to CRAs, • Tracking patient enrollment, conducting site qualification/initiation/close-out activities, and supporting data management coordination, • Managing study supplies and negotiating vendor contracts, • Reviewing ICFs, CRFs, and study-related materials, • Planning and participating in investigator meetings, • Supporting the data query process, • Ensuring regulatory compliance and maintaining an up-to-date Trial Master File Essential Requirements: • BA/BS degree or nursing qualification (science preferred), • Minimum 5 years' experience in clinical studies, including at least 1 year of site management, • Previous monitoring or study coordination experience preferred, • Strong knowledge of GCP and SOPs, • Understanding of clinical study phases, • Ability to work independently and within cross-functional teams, • Advanced proficiency in Word, Excel, and PowerPoint, • Experience with electronic systems such as TMF, CTMS, Veeva Vault, Smartsheet, and SharePoint, • Strong communication skills, • Willingness to travel 10–20% To express interest or learn more about this opportunity, please get in touch. Advanced Clinical offers a collaborative environment where your contributions directly support the success of innovative clinical research.

Medical Director, Ophthalmology (Clinical Development) MD or PhD required | Ophthalmology experience essential We are seeking a senior Medical Director with deep ophthalmology experience to lead global clinical development programs in this space. This is a high-impact leadership role responsible for defining and executing clinical strategy across ophthalmology studies, from first-in-human through Phase 3. You will provide medical and scientific leadership across trial design and execution, including protocol development, feasibility, site strategy, enrolment planning, and safety oversight. Acting as the primary medical authority, you will partner closely with cross-functional teams, investigators, and external experts, offering guidance on disease biology, benefit–risk assessment, and regulatory standards. This role plays a key part in medical data review, safety monitoring, and contributions to regulatory submissions and interactions with health authorities. You will also build and maintain strong relationships with key opinion leaders, ensuring programs remain scientifically robust and competitive within the ophthalmology landscape. Required Experience and Background • MD, MD/PhD, or PhD is mandatory (ophthalmology degree not required, but ophthalmology experience is essential), • Proven experience in ophthalmology clinical development, ideally including retinal or inherited retinal diseases, • Background in pharma or biotech in roles such as Medical Director, Associate Medical Director, or Clinical Scientist, • Strong expertise in clinical trial design, GCP, regulatory requirements, and medical monitoring, • Experience with safety oversight, pharmacovigilance, and data review, • Familiarity with ophthalmic assessments and imaging (e.g., OCT, fundus photography) is highly desirable, • Ability to lead scientific discussions, influence stakeholders, and operate strategically in a fast-moving environment

Planet Pharma are seeking highly experienced and strategic Directors of Biostatistics (both Oncology and Non-Oncology) to lead statistical activities across a portfolio of clinical trials, spanning early to late phase development. This is a senior individual contributor role, ideal for someone who thrives in a hands-on, scientifically driven environment and prefers to focus on project leadership rather than people management. 🎯 Key Responsibilities • Serve as the lead biostatistician on multiple oncology studies (Phase I–III), ensuring statistical integrity and regulatory compliance throughout the trial lifecycle., • Provide strategic input into protocol design, statistical analysis plans (SAPs), and clinical development strategies., • Collaborate cross-functionally with clinical, regulatory, data management, and programming teams to ensure robust statistical deliverables., • Represent biostatistics in internal governance meetings, sponsor interactions, and regulatory submissions., • Review and interpret statistical outputs, author statistical sections of clinical study reports (CSRs), and contribute to publications and presentations., • Stay abreast of methodological advances in oncology statistics and apply innovative approaches where appropriate. 🧠 Qualifications & Experience • PhD or MSc in Biostatistics, Statistics, or a related field., • Minimum 10 years of experience in clinical trial biostatistics ideally within a sponsor organization., • Proven track record of leading statistical strategy for early and late phase trials., • Deep understanding of regulatory guidelines (e.g., ICH, EMA, MHRA) and experience with submissions., • Proficiency in statistical software (e.g., SAS, R) and CDISC standards., • Excellent communication and scientific writing skills. 🌍 Work Environment • Fully remote role based in the UK., • Flexible working hours with occasional travel for team meetings or sponsor engagements., • Collaborative, science-driven culture with a focus on innovation and patient impact.

Kapadi is a full service CRO that focuses on complex oncology indications including immunotherapy and cellular therapies. We know that innovative research requires innovative operations and we've built that into our culture, systems and processes. We have an infrastructure to enhance access to patients and integrated technology to provide higher quality and faster access to results. We are looking for a highly-motivated Clinical Research Associate II - Study Start-Up and Maintenance to help us continue to grow our business and deliver new, life-changing therapies for the cancer patients who need them. As a Clinical Research Associate II - Study Start-Up and Maintenance, you will: • Perform study startup and regulatory document maintenance activities for Phase I-IV clinical research projects., • Assess the progress of clinical projects at assigned sites and ensure clinical projects are conducted, recorded and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements., • Serve as the primary liaison between site and project team throughout the study lifecycle, from site identification through close-out related to site start-up support and regulatory document maintenance. Respond to site concerns and questions as applicable., • Document activities via communication logs and other required project documents as per SOPs and project plans. Enter data into tracking systems as required to track all observations, ongoing status and assigned action items for resolution., • Manage, coordinate and perform Central IRB submissions for North America and local CTIS submissions for Europe, including but not limited to: initial submissions, amendment submission, changes of PIs, safety submission, annual reviews etc.., • Assist the project team with the creation and finalization of the Clinical Site Activation Plan., • Routinely mentor junior level team members. Knowledge, skills and abilities: • Demonstrated knowledge of the clinical research and development process in pharmaceutical and/or biotechnology industries., • Demonstrated ability to lead and coordinate study start-up and regulatory activities for large-scale clinical trials., • Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements. Requirements: • Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience., • Minimum of 3 years of experience in clinical R&D in pharmaceutical, biotechnology and/or clinical research organization (CRO) businesses, including at least 2 years of experience in a CRO providing clinical research services to pharmaceutical, biotechnology or medical device companies., • 5+ years of experience in a study start-up position. Candidates who also bring in experience in compiling EU CTR submissions via CTIS in Ireland or even other EU CTR countries and with additional language skills are preferred. This position is homebased!

About the Company A fast-growing global medical technology company is redefining how diagnostics are performed in clinical laboratories. Through the application of advanced imaging and AI-driven solutions, their platform enables high-resolution digital review of samples, improving diagnostic efficiency, accuracy, and overall laboratory workflow. With strong investment and a clear growth strategy through 2026, the company is driving the shift toward digital transformation and automation across hematology and wider diagnostic fields. About the Role We are seeking a Field Application Specialist to join a world class customer success and implementation team. This position bridges science, technology, and clinical practice, helping laboratories integrate advanced AI powered digital solutions that replace traditional manual workflows. You will work across pre-sales, installation, training, and ongoing customer support, collaborating closely with commercial, technical, and R&D teams to ensure a seamless customer experience. What You Will Be Doing Implementation and Training • Lead implementation and integration of digital diagnostic solutions with customer systems and middleware, • Conduct on site and virtual user training sessions, workshops, and validation support, • Guide customers through regulatory and validation requirements for system deployment Technical Support and Troubleshooting • Provide expert pre and post sales technical support, • Collaborate with engineering teams to resolve complex issues and ensure product reliability Customer Success and Feedback • Partner with laboratories to optimize digital workflow adoption and ROI, • Gather user insights and performance data to help shape product improvements, • Maintain trusted, long-term relationships with clinical users and key stakeholders Sales Support • Support demonstrations at conferences, trade shows, and customer sites, • Collaborate with commercial teams to drive engagement and adoption About You • Minimum two years of experience in a hematology or clinical laboratory environment, • Hands on experience with blood smears, bone marrow analysis, or cell morphology, • Excellent communication and presentation skills, confident leading training and supporting customers, • Passionate about AI, digital transformation, and innovation in healthcare, • Flexible to travel up to 50% Region Specific Requirements United Kingdom • Must have completed the IBMS Registration Portfolio and obtained the IBMS Certificate of Competence, • HCPC registration required

Chief Data Officer – UK or Poland (Home‑Based) Executive Leadership | Data Strategy | Enterprise Transformation A leading global life‑sciences organisation is seeking an accomplished Chief Data Officer (CDO) to drive enterprise‑wide data strategy, architecture, and transformation. This is a senior, VP‑level position with responsibility for shaping and delivering the company’s data vision while leading a high‑performing team of Senior/Executive Directors across the UK and US. About the Role The CDO will report directly to the Chief Information Officer and will lead a specialist team of 4–5 senior data leaders. This is a strategic‑technical hybrid role requiring both high‑level vision and hands‑on capability. Candidates must be able to define enterprise data direction while also diving into architecture, tooling, design, and delivery where necessary. This position is home‑based and can be performed from the UK or Poland. Key Responsibilities • Define and execute the organisation’s enterprise‑wide data strategy, • Lead data transformation initiatives across architecture, governance, quality, and operations, • Oversee creation of data lakes, warehouses, lakehouses, and modern data platforms, • Drive the transition to Azure-based cloud environments and modern engineering practices, • Build an enterprise data model capable of standardising sponsor data received in various formats, • Develop and implement Medallion Architecture (Bronze/Silver/Gold layers), • Guide the ingestion, curation, standardisation, and consumption of data, • Deliver scalable data solutions that support multi‑tenancy and SaaS offerings, • Lead innovation and champion data‑driven improvements across the organisation, • Manage a senior team responsible for data engineering, architecture, governance, and strategy What We’re Looking For Industry Experience (mandatory): • Pharma, biotech, healthcare, or broader life‑sciences data leadership, • (Candidates outside these industries will not be considered.) Technical & Strategic Expertise: • Proven background in enterprise‑level data transformation, • Experience handling legacy data, migrations, and modernisation projects, • Strong knowledge of Microsoft Azure, data engineering, and cloud‑native tools, • Deep understanding of Medallion Architecture (Bronze/Silver/Gold), • Experience building data lakes, lakehouses, and large‑scale data ecosystems, • Ability to design multi‑tenant SaaS data solutions and data‑slicing approaches, • Strong familiarity with Snowflake or similar technologies, • Ability to define and implement enterprise data models, • Strong understanding of data integration challenges, including data lineage and sponsor integrations Leadership & Delivery: • Executive‑level stakeholder management, • Ability to articulate and deliver a compelling vision for data transformation, • Demonstrable track record of innovation in data strategy and architecture, • Experience leading senior technical leaders (Directors/Exec Directors) Interview Structure • Stage 1: VP, Global Head of Clinical Technology & Strategy, • Stage 2: Head of Product Management & Engineering, • Final Stage: Chief Information Officer Examples of Areas Candidates Will Be Assessed On Candidates should be prepared to discuss: • How they would build an enterprise data ecosystem from scratch, • Approach to addressing data lineage/data length issues with large sponsor integrations, • Real examples of innovations they have delivered and their business impact, • Designing a multi‑tenant SaaS data environment, including data slicing, • How to implement Medallion Architecture and manage heterogeneous sponsor data inputs

Systematic Literature Reviewer / Evidence Synthesis Consultant An exciting opportunity to join a steadily growing Global HEOR consultancy with one of the best staff turnover rates in the entire healthcare consulting space, offering full remote flexibility, a healthy work life balance and genuinely people focused, fun culture! You'll be joining a technically-excellent, supportive, and friendly team, that pride themselves on a inclusive and collaborative culture, a fun, personable company, where technical teams work closely with each other, enabling all to learn from some of the best minds in the industry. The role The purpose of the role is to support and lead on the design and execution of clinical, economic and quality of life systematic literature reviews. You will work alongside expert technical teams to support development of health technology assessment submission dossiers or work with internal systematic review analysts and statisticians to conduct de novo global literature reviews. Role scope/responsibility: Conduct and help supervise systematic literature review and evidence synthesis projects: • Design, • Running of searches, • Review of title, abstract and full papers, • Data extraction, • Quality assessment, • Reporting Undertake and assist in project management activities on SLR projects: • Project planning, • Client communication, • Managing/reviewing the work of other SLR analysts Ideal profile: • MSc/PhD in relevant field, • Extensive SLR experience, including clinical and economic SLR, • Minimum 3+ years in a consulting firm/CRO highly desirable or several years relevant academic or public sector setting, • Hands on experience of network meta-analysis an advantage, but not essential, • Exposure to HTA processes and Pharma clients/private sector clients This is a technical hands on position, giving you a pathway to develop leadership, client management and commercial skills, or stay in the 'technical SME lane' under the guidance and support of an established leadership team. The choice is yours! Apply now for more info on the role, company, and to discuss your motivations in more detail.

Director – Clinical Development // Develop the next Ophthalmology blockbuster // Remote You are an experienced in clinical development and have a strong expertise in back of the eye diseases. Why have you dedicated your career to the clinic? To develop new drugs meeting real unmet need for patients? We are working with an Italian pharma who specialise in developing drugs for rare and complex diseases within the ophthalmology, CNS, and immunology. A private company with significant resources, a long-term view, a dynamic, fast-paced mindset, and a real track record of success. They are looking for a Director Clinical Development to drive an Ophthalmology growth-factor which has best-in-class potential (and has been awarded an FDA voucher after incredible preclinical data for a rare disease) from phase I through IV. You will lead significant projects in a very important program (which you will co-lead), have strategic input, and significant influence over the direction of ophthalmology clinical development. You will join a world class team that has already taken ophthalmology drugs to market and have a real impact on the team’s ability to become even more successful. If you are an industrial (CRO, pharma, biotech) expert in clinical development with experience in ophthalmology (back of eye diseases), ready to revolutionise patient care within ophthalmology, apply here or reach out to We look forward to hearing from you.

Medical Nutrition Manager (Remote – Full Time, 12 months – Maternity Cover) Department: Market Engagement Job Type: Full-time, Permanent Location: Remote (UK) Salary: Competitive + excellent benefits Are you a clinically credible, commercially minded medical nutrition expert who thrives at the intersection of science, regulation, and market engagement? This is a pivotal opportunity to shape how evidence-based medical nutrition is positioned, communicated, and trusted across the healthcare landscape. About the Role As Medical Nutrition Manager – Market Engagement (MNM-ME), you’ll be a senior scientific and regulatory authority within our Market Engagement team. You’ll ensure all product communications, packaging, and campaigns are scientifically robust, fully compliant, and strategically aligned with business objectives. This role blends Medical Affairs, Regulatory Compliance, and Commercial Engagement, supporting product innovation, brand integrity, formulary access, and meaningful engagement with HCPs, KOLs, NHS stakeholders, and regulatory bodies. Key Responsibilities Clinical & Scientific Leadership • Act as the internal expert on medical nutrition science, FSMP regulations, and Medical Affairs, • Translate clinical evidence into compelling, compliant value propositions, • Partner with Marketing, Commercial, and Market Access teams to deliver credible, compliant campaigns, • Support KOL engagement, NHS/private sector relationships, and ACBS positioning, • Review and approve packaging artwork, labelling, and patient materials (FSMP, FIC, MHRA), • Ensure accuracy of nutritional data, claims, allergens, and mandatory statements, • Interpret and communicate clinical studies and product evaluations, • Support publications, abstracts, white papers, and health-economic data, • Ensure compliance with ABPI, PAGB, EFSA, MHRA codes and internal SOPs, • Support ISO 9001, ISO 14001, and B-Corp objectives, • Collaborate across QA, Supply Chain, Product Development, PR, ESG and Commercial teams Requirements • Degree in Nutrition, Dietetics, or Life Sciences (postgraduate desirable), • HCPC registration or equivalent, • 5+ years’ experience in medical nutrition / FSMP / healthcare, • 3+ years’ experience across Medical Affairs, Regulatory Compliance, packaging sign-off, and cross-functional market engagement, • Strong knowledge of ONS products, FSMP regulations, ACBS processes, and NHS procurement, • Experience translating science into effective, compliant marketing and education, • Confidence presenting at conferences and engaging senior stakeholders, • Commercial acumen, supplier management experience, and ESG awareness, • A proactive, solutions-focused mindset with exceptional attention to detail, • Self-starter with ability to work independently, • Proficient with Microsoft 365 (including Teams), • Team player with a proactive, “can-do” attitude, • Confident working independently in a remote environment What We Offer • Fully remote working (UK-based role), • Competitive salary (dependent on experience), • Collaborative, supportive culture with room for innovation and ownership, • Work with purpose in the healthcare sector, making a meaningful impact Who are AYMES? AYMES is an innovator in the Oral Nutrition Supplements sector. We have achieved remarkable and continued growth, and we have ambitious strategic plans to grow our portfolio. We provide the NHS with highest quality, best value Oral Nutrition Supplements and are regularly voted the best tasting product in the ONS sector. We are a team of agile, dynamic, and innovative individuals striving to continue moving quicker and faster. Why AYMES? At AYMES we believe in creating an environment where everyone can thrive. Our team is made up of the most talented in their fields of expertise and we believe that every individual brings unique and valuable insight into our business. Working for AYMES you’ll get… • To be part of a forward-thinking B-Corp certified business, • Fully remote working, • 3 paid Charity Engagement days to allow you to support causes close to your heart, • 25 days annual leave, • Flexible benefits, • A Strengths based environment that supports you flourish with your natural talents as well as your learned skills

Clinical Pathologist Hybrid / Remote (depending on location) Permanent Full-time, 40 hours per week. Participation in a Saturday service rota required. £95,000 - £110,000 We’re excited to welcome a Clinical Pathologist to our expanding Antech UK team. This is a great chance to join a collaborative, international network of Clinical and Anatomic Pathologists. At Antech, part of Mars Petcare, we are all united by one mission: A Better World For Pets. You’ll work with a varied caseload, ranging from first-opinion submissions to complex referral hospital cases, ensuring your work stays diverse, challenging, and rewarding. Primary duties include: • Examination and reporting of cytology samples – fine needle aspirates, effusions, CSF, synovial fluid., • Evaluation and interpretation of clinical pathology results, including haematology, biochemistry, endocrinology and microbiology, • Evaluation and reporting of flow cytometry, • Evaluation and reporting of bone marrow histology, • Contributing to the training of clinical pathology residents as well as visiting residents, • Contributing to the training of lab technicians in blood film examination, • Taking part in seminars and journal clubs Requirements: • Board certified by the European College of Veterinary Pathologists, American College of Veterinary Pathologists or Royal College of Pathologists., • You will be organised, hardworking and self-motivated with an enthusiasm for science, • Candidates must be able to work within a multidisciplinary team but also autonomously within the laboratory environment. Benefits: • Remote, Hybrid or On-site working, • 5 weeks holiday plus bank holidays and Birthday Leave, • Career progression opportunities, • Staff discount schemes, • Private Health Insurance, • Life Assurance, four times your salary, • Enhanced sickness pay, • Enhanced equal family leave, • E-car salary sacrifice scheme, • Employer contribution pension scheme, • Wellness program including: Employee assistance program, Eyecare voucher scheme, Free annual Flu jab, • Cycle to work scheme, • Retail, Restaurant and Cinema discounts, • Recruitment referral reward scheme About us Antech is a leader in veterinary diagnostics, driven by our passion for innovation that delivers better animal health outcomes. Our products and services span 90+ reference laboratories around the globe; in-house diagnostic laboratory instruments and consumables, including rapid assay diagnostic products and digital cytology services; local and cloud-based data services; practice information management software and related software and support; veterinary imaging and technology; veterinary professional education and training; and board-certified specialist support services.

Senior Clinical Research Associate – England Chloe O’Shea is proud to partner with a leading global CRO renowned for delivering innovative, high-quality solutions in clinical development. We are seeking an experienced Senior Clinical Research Associate (Senior CRA) to join a dedicated single-sponsor team in England. This is an exciting opportunity to work on cutting-edge studies, with a particular focus on advanced therapy areas such as CAR-T and gene therapy. While prior experience in these fields is highly valued, it is not essential - full training and support will be provided. The Role As a Senior CRA, you will be a key contributor to the successful delivery of clinical trials across England. You will oversee site management activities, act as a primary liaison with investigative sites, and ensure strict compliance with protocols, ICH-GCP, and UK regulatory requirements (MHRA/REC). This role is well-suited to ambitious CRAs ready to step up or established Senior CRAs seeking to deepen their expertise in innovative therapy areas. Key Responsibilities • Independently manage qualification, initiation, monitoring, and close-out visits across England., • Ensure high standards of compliance with ICH-GCP, MHRA, REC requirements, and sponsor SOPs., • Perform source data verification, investigational product accountability, and ensure accurate site documentation., • Serve as a trusted partner to site personnel, offering training, guidance, and ongoing support., • Identify site-level challenges proactively and drive timely resolution., • Contribute to mentorship of junior CRAs and share best practices within the monitoring team., • Maintain complete and accurate trial documentation in CTMS, eTMF, and EDC systems. Requirements • Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related discipline., • Minimum 3 years of independent UK monitoring experience, ideally with exposure to complex studies., • Experience in CAR-T and/or gene therapy is highly desirable but not required., • Strong knowledge of ICH-GCP and UK clinical trial regulations (MHRA/REC)., • Excellent communication, relationship-building, and organisational skills. What’s in It for You? This role offers a competitive salary and benefits package, flexible working arrangements, and clear opportunities for career progression within one of the world’s largest CROs. You’ll gain exposure to innovative therapies shaping the future of healthcare, while working in a collaborative culture that values professional development, work-life balance, and wellbeing. If you are a driven Senior CRA — or an experienced CRA ready to take the next step — we’d love to hear from you. Apply today to join a global team making a meaningful difference in patients’ lives.

Carrot Recruitment is proud to be partnering exclusively with an innovative, global medical device company. Our client is seeking a Clinical & Technical Support Specialist to join their UK team with a focus on cardiology. This is a highly patient-facing role combining clinical expertise, technical support, education, and stakeholder engagement. Everything you need to know about the role Following comprehensive training your responsibilities will include: • Coordinating and conducting patient fittings across requesting hospitals throughout the UK (with occasional travel to the Republic of Ireland)., • Acting as the first point of contact for patients and physicians, providing technical and clinical support via phone and delivering tailored solutions., • Analysis of ECG data and other technical information, taking appropriate action and ensuring accurate documentation in line with company guidelines., • Network and portal management, • Delivering customer-facing training and first-line education, working closely with therapy development colleagues., • Attending relevant UK cardiology congresses and meetings., • Supporting national initiatives to grow awareness of the therapy through effective presentations and customer engagement., • Collaborating with Customer Service on projects, process improvements, and service delivery. To be successful in this role, you will bring: • Previous experience in cardiology within a clinical or hospital environment (preferred), • Interest in working in the medical device industry, • Willingness and flexibility to travel as required, sometimes on short notice, • A goal-oriented, hands-on approach with persistence and accountability, • Strong working knowledge of various Microsoft office programmes, • A motivated, independent, and patient-focused mindset with a calm and level headed demeaner, • Strategic thinking and ability to manage logistics, • Excellent interpersonal and communication skills, with the ability to build trust with patients, clinicians, and colleagues, • Fluency in written and spoken English What’s on offer? • Base salary of up to £45,000 per annum (depending on experience), • Work with a life-saving cardiac technology that makes a real difference to patient outcomes, • Receive extensive training and development in a specialist cardiology therapy, with opportunity to progress with the company, • Enjoy a varied role combining clinical work, technology, education, and travel Could this be the role for you? If you’re ready to take on this exciting opportunity and bring your expertise to a company that’s shaping the future of healthcare, we’d love to hear from you. Please note that we do expect a high level of interest on this role, suitable candidates will be contacted as soon as possible. Applications may be paused once the interview process starts and reopened as required.

Key aspects of the role include: Salary Range: £68,437.82 to £76,236.77 • Delivering highly specialist nutritional assessment, formulation, and intervention for children and young people with Eating Disorders, ARFID, and complex mental-health–related nutritional needs., • Acting as the dietetic lead within the CAMHS Eating Disorder Pathway, providing expert input to multi-agency formulation and care planning., • Offering consultation, reflective guidance, and training to colleagues, partner agencies and the wider community to strengthen trauma-informed, recovery-focused care., • Prescribing dietary products and enteral feeds and interpreting medical/biochemical data to support safe, evidence-based treatment., • Contributing to clinical governance, audit, research activity, and the development of guidelines and patient information resources., • Supporting the Nutrition & Dietetics service with student training and professional development. Our Specialist Eating Disorder Dietitian will provide advanced clinical expertise to children and young people presenting with disordered eating, ARFID and complex mental health presentations. You will work closely with psychiatry, psychology, nursing and family therapy colleagues to deliver integrated, safe and evidence-based treatment. As the senior dietetic voice within the pathway, you will contribute to MDT formulation, risk management and standardised care planning, ensuring consistent, high-quality dietetic input across CAMHS and partner services. This is a rare opportunity to help shape the development of Jersey’s specialist Eating Disorder offer, influencing practice, pathways and training across CAMHS and the wider system. The role is dedicated to improving nutritional health, recovery and life outcomes for young people with eating difficulties. If you are motivated, skilled and passionate about specialist dietetic care in child and adolescent mental health, we would love to hear from you. About You You will be a HCPC-registered Dietitian with substantial post-registration experience, including work with eating disorders, child and adolescent mental health, or complex paediatrics. You will bring highly specialist knowledge, strong clinical reasoning and the ability to work autonomously while also contributing to multi-agency, trauma-informed care. You will be confident in delivering consultation, education and collaborative practice, with excellent communication and leadership skills that enable you to influence system-wide change. Join us in shaping a compassionate, progressive and evidence-driven service where young people’s physical and psychological recovery is supported through integrated, multidisciplinary care. For a full job description, click here: ___ For more information or an informal conversation, please contact: Lee Hayward – Service Manager, CAMHS or Richard Dyer – Head of Children’s Health & Wellbeing (CAMHS) Application Closing Date 9th January 2025 Island life Living in Jersey offers the opportunity to be part of a beautiful island with a close-knit community, where you can make a meaningful difference to children and families while enjoying an excellent quality of life. Our smaller population allows clinicians to work closely across systems, influence service development and experience the impact of their work every day. Further information about relocating to Jersey is available here:

Job Title: Nurse Manager Contract: Permanent, Full-time (37.5 hours per week) Monday to Friday Location: Home based with travel as required Salary: Up to £48,000 per annum As Nurse Manager at Medigold Health, you will be responsible for leading a team of Occupational Health Advisors, Nurses, and Technicians to ensure the consistent delivery of high-quality clinical services to our clients across the UK. You will play a vital role in maintaining clinical excellence, supporting professional development, and ensuring that our service aligns with the highest standards of patient care, compliance, and client satisfaction. Drawing on your clinical expertise and leadership experience, you will oversee day-to-day team management, support with recruitment and onboarding of new team members, and provide guidance on complex case management referrals. You’ll also take the lead in clinical audits, help manage complaints, and support our Associate Director of Nursing in shaping and developing our service offering. Whether conducting virtual team meetings, supporting revalidation processes, or attending client implementation meetings, you’ll play a key role in driving service improvement and championing best practice across the business. You will also act as a clinical ambassador for Medigold Health, promoting our Occupational Health services and helping us build long-term partnerships with our clients. This is an exciting opportunity to step into a strategic and people-focused leadership role, where you can help shape the future of Occupational Health and play a key part in supporting the wellbeing of employees nationwide. Main Objectives • Practice within the scope of the NMC professional practice and Code of Conduct and to work according to qualification, experience, and competency., • Responsible for the day-to-day personnel management of a team of allocated OHAs and Nurses and technicians., • Active participation and flexibility to support recruitment activity for all nursing teams., • The delivery of the Occupational Health Service to Medigold clients ensuring the provision of the occupational health advice is always of the highest standard., • To act as an ambassador and promote the Occupational Health services available., • To ensure clinical standards of best practice are followed and company policies and procedures are adhered to., • To fully utilise company IT systems in the performance of duties., • Undertake clinical supervision/peer and team audit in relation to service delivery as identified., • Undertaking investigation and response to queries and complaints arising from team activities, • Taking on a clinical lead role as required Specific Responsibilities • Work autonomously and as part of the Medigold Health multi-disciplinary team to ensure that a satisfactory level of service is provided to all clients and their employees achieving current service level agreements this includes the completion of all clinical administration., • Ensure skills and competencies are maintained to undertake core Occupational Health activities as required., • Ensure that CPD and other training needs are undertaken to ensure compliance with NMC requirement for continuing registration. Maintain evidence in support of Revalidation., • Ensure familiarity with the requirements of all appropriate client contracts and Aide Memoirs., • Maintain, store, and handle medical records in accordance with Medigold-Health Data Protection Policy and GDPR requirements in order to preserve and respect client and employee medical confidentiality., • Liaise with other service teams regarding both client and patient queries., • Maintain Supervisory personnel Records for all team members., • Undertake interviews, inductions, training, and appraisals for all team members to support continual professional development., • Attend tender, client review and implementation meetings as required., • Maintain competency matrix for all team members and provide support to fulfil NMC revalidation and maintain clinical competence., • Assist Associate Director of Nursing in the organisation of any required clinical OHA training., • Attend and actively participate in meetings as requested., • Undertake regular scheduled Clinical audit as required., • Take accountability for identifying, and boldly influencing and implementing improvements to the service provided from a clinical perspective, looking for opportunities to extend the Occupational Health products being offering. Requirements for this role • Trained to undertake all core Occupational Health clinical skills., • Experienced skills and competency with case management activities undertaking complex referrals, • Occupational Health degree/Diploma & NMC registration is essential., • Previous managerial and people management experience is essential., • Demonstrable experience within Occupational Health departments, preferably private sector experience., • Experience of participation in tender support meetings and presentations to potential clients would be beneficial. Our Company Benefits • 31 days holiday inclusive of bank holidays, increasing with length of service, • Contributory pension scheme up to 5%, • Paid Professional Memberships and Indemnity Insurance, • Access to Company benefits and discount portal, • Access to a Health Cash Plan, • Free eyecare vouchers, • Cycle to work scheme, • Access to confidential Employee Assistance programme, • Interactive mental health and wellbeing app

Clinical Application Manager Full-time | 37.5 hours per week | Monday–Friday We are seeking a dynamic and forward-thinking Clinical Application Manager to join our Group IT function. This is an exciting opportunity to play a key role in shaping the technology that underpins clinical excellence across a large, complex, and fast-moving healthcare organisation. What You’ll Bring • 3+ years’ experience supporting and managing clinically facing IT applications within large-scale organisations (approx. £250M+ revenue, 5,000+ users, 20+ sites)., • 3+ years’ team leadership experience, including managing complex workloads and delivering large-scale projects., • A strong background in service delivery, including managing relationships with third-party suppliers., • Up-to-date understanding of data protection, information security, and information governance., • Exceptional interpersonal and customer-focused skills, with the ability to build strong relationships across clinicians, operational teams, IT colleagues, and suppliers., • Proven analytical and problem-solving ability, including data analysis and reporting using established tools., • The ability to translate technical information into clear, accessible language for non-technical audiences., • Experience in mentoring, coaching, and developing team members., • Experience working in a private healthcare clinical or IT environment., • ITIL certification (required)., • Experience in designing and delivering application training., • High levels of self-motivation, organisation, and initiative, with a proactive approach to personal development and continuous learning., • Lead, mentor, and manage a team of clinical application specialists, providing direction, support, and ongoing professional development., • Foster an inclusive, collaborative team environment that champions knowledge sharing, continuous improvement, and innovation., • Conduct regular performance evaluations, set clear objectives, and provide constructive feedback to support growth., • Oversee the development and implementation of strategies that enhance, evolve, or replace clinical applications - driving efficiency, supporting high-quality patient care, and enabling operational innovation., • Manage the ongoing maintenance and optimisation of clinical applications, ensuring performance, stability, security, and alignment with evolving organisational needs., • Create, maintain, and continuously improve robust testing methodologies to ensure consistent, high-quality testing of upgrades, new functionality, and new systems - working closely with suppliers and internal teams to identify and resolve issues.

About Veramed At Veramed, we focus on two key areas: delivering exceptional statistical and programming consultancy, and creating a workplace where our people can thrive. We’re committed to supporting your career goals through tailored development opportunities - all within a collaborative, forward-thinking environment. We are taking applications from applicants across Europe - working arrangements to be discussed further during an introductory call. The Opportunity We’re seeking a dynamic and visionary leader to join us as Head of Projects - a pivotal role with full ownership of our Projects Division. This is a rare opportunity for a Vice President or COO-level professional to lead a high-performing business unit within a growing CRO, driving strategic growth, operational excellence, and innovation in biometrics. Key Responsibilities • Define and execute the strategic vision for the Projects Division., • Lead cross-functional teams across Data Management, Statistics & Programming, Strategic Consultancy, and more., • Own the division’s P&L, driving revenue, margin, and commercial success., • Oversee delivery excellence, quality standards, and client satisfaction., • Build and maintain strong client relationships at the executive level., • Inspire and develop high-performing teams, fostering a culture of innovation and continuous improvement. What You’ll Bring • 10+ years of leadership experience in life sciences project-based service delivery., • Proven track record managing P&L with revenues exceeding £10M., • Deep expertise in biometrics, clinical research, or regulated industries., • Strong commercial acumen and strategic thinking., • Exceptional leadership, communication, and stakeholder management skills. What You Can Expect from Us • A seat at the executive table with real influence and autonomy., • A collaborative, values-driven culture that prioritizes people and purpose., • Exposure to innovative projects and top-tier clients., • Competitive executive compensation and benefits., • A chance to shape the future of biometrics - and how it’s delivered. Diversity & Inclusion at Veramed We are proud to be an equal opportunities employer. At Veramed, we celebrate diversity and are committed to creating an inclusive environment for all. We welcome applicants from all backgrounds and walks of life. Ready to lead a division where biometrics are built better? Apply now and help shape the future of Veramed.

Director – Clinical Development // Develop the next Ophthalmology blockbuster // Remote You are an experienced in clinical development and have a strong expertise in back of the eye diseases. Why have you dedicated your career to the clinic? To develop new drugs meeting real unmet need for patients? We are working with an Italian pharma who specialise in developing drugs for rare and complex diseases within the ophthalmology, CNS, and immunology. A private company with significant resources, a long-term view, a dynamic, fast-paced mindset, and a real track record of success. They are looking for a Director Clinical Development to drive an Ophthalmology growth-factor which has best-in-class potential (and has been awarded an FDA voucher after incredible preclinical data for a rare disease) from phase I through IV. You will lead significant projects in a very important program (which you will co-lead), have strategic input, and significant influence over the direction of ophthalmology clinical development. You will join a world class team that has already taken ophthalmology drugs to market and have a real impact on the team’s ability to become even more successful. If you are an industrial (CRO, pharma, biotech) expert in clinical development with experience in ophthalmology (back of eye diseases), ready to revolutionise patient care within ophthalmology, apply here or reach out to We look forward to hearing from you.

An experienced Clinical Data Manager is required to join a European consultancy on an initial 12 month contract. The successful candidate will work across projects for a global pharmaceutical company. Full and part-time opportunities available. Applicants must be based in the EU or the UK, and will ideally have comprehensive experience in Veeva EDC. Experience in SAS, Pinnacle 21 and CDISC, SDTM, CDASH is also preferred. Responsibilities will include: • Perform all data management activities from study start up to database lock, • Create study related documents (data management plan, CRF completion guidelines, laboratory specifications, edit check specifications), • Perform Data Review and query resolution, • Design Case Report Forms, • Annotate CRFs or eCRFs, • Program edit checks, • Perform medical dictionary coding, • External data file import and reconciliation, • Manage CRO’s and external vendors, • Database development and design, • Working knowledge of industry standards, e.g. CDISC, SDTM, CDASH For additional information, and a confidential discussion, please apply now with an updated CV.

A Global leader in Pharma is seeking a Scientific Publications professional to support global data dissemination and advance scientific and medical understanding of their products and therapeutic areas. In this role, you will collaborate across a global matrix environment to help develop and execute publication plans for assigned products. Key Responsibilities • Translate medical strategies into actionable, globally aligned publication plans, • Support timely execution of publication activities, including vendor management, • Apply good publication practices and ensure compliance with global SOPs and documentation requirements, • Review publication drafts for scientific quality and alignment with author direction, • Track budgets, report on progress, and contribute to internal publication metrics, • Build effective relationships with internal teams, academic experts, and external partners, • Provide input on publication strategy based on disease-area knowledge, clinical development timelines, and the evolving scientific and regulatory landscape, • Participate in cross-functional medical teams and liaise with global, regional and affiliate Medical Affairs colleagues Professional Profile • Advanced degree (PharmD, PhD, MD) in a scientific or medical discipline, • 3+ years’ experience in healthcare, academia, clinical research, or medical/technical writing, • Strong understanding of good publication practices (ICMJE, GPP3, IFPMA, etc.) and global transparency requirements, • Experience in ophthalmology and managing publications in a global matrix environment, • Skilled in scientific writing, editing, problem-solving and managing multiple priorities, • Familiarity with publication management systems and clinical trial data, • Proven ability to collaborate with vendors and cross-functional partners If interested then please apply and I will arrange a confidential call to discuss the role further.

Regulatory Affairs Director Our client is a young exciting publicly listed clinical-stage company dedicated to transforming the lives of patients in its therapy areas. With its novel and proprietary drug products and current clinical development programs our client is aiming to provide improved treatments for patients with increased remission rates, faster onset of action, durable effects, and improved tolerability and convenience. This requires experience and a track record of successful development in complex and innovative areas, and excitement for creating something new and groundbreaking. Job Spec To help achieve their mission, the role will provide the rare opportunity for a high-performing, innovative thinker to play a role in transforming the treatment of neuropsychiatric disorders by supporting the development of next-generation mental health therapies from concept to reality. For this reason, we’re looking for a Director of Regulatory Affairs to work closely with the existing regulatory team, internal and external experts, and collaborate and contribute towards successful execution of our pivotal clinical program and commercialization. This requires practical experience and a proven track record in overseeing clinical regulatory activities in complex and innovative areas, preferably in CNS/psychiatry, including Sponsor oversight of CTAs and managing in-house clinical trial preparations, and a passion for creating something new and ground breaking. The ideal candidate will bring a proven track record in the development of drug-device combination products from a clinical regulatory perspective. Manage in-house preparation and execution of clinical trial applications, ensuring compliance with regulatory requirements and company timelines. Oversee submissions made by regulatory vendors on the sponsors behalf to ensure a high standard of quality is maintained. Provide RA review of essential clinical study/submission documents e.g. clinical protocols, IMPDs, IBs, CSRs and informed consent forms. Provide hands-on guidance and oversight of future global marketing authorization applications, in line with regulatory guidelines. Act as RA representative on product development teams as assigned. Provide RA guidance and oversight in line with corporate objectives. Interface with regulatory agencies on aspects of clinical studies as appropriate with oversight of RA Management. Work with the technical development and device regulatory team as required in the development of drug-device combination products, in line with current regulatory requirements. Maintain RA submission and correspondence archives in compliance with document retention policies. Proactively identify changes in global regulatory landscape that may impact activities, provide RA intelligence to internal stakeholders and assist in preparing the organization for any internal adaptation that may be required. Author, review, and update RA SOPs as needed, with emphasis on clinical regulatory processes. Maintain links with external regulatory network, proactively identify training/development needs and identify opportunities to further regulatory knowledge in clinical areas. Maintain a professional and credible image with regulatory agencies, consultants, vendors, colleagues. Person Spec RA experience in biotech companies of at least 8 years, with strong focus on clinical development including practical oversight of CTAs as a sponsor and hands-on management of in-house clinical trial preparations. Experience with international (US, EU and UK) regulatory dossier preparation (e.g. CTA/MAA or IND/NDA), including eCTD requirements Direct experience of CTIS is beneficial. Experience of participation / leading regulatory interactions with key agencies, including US FDA and EMA. Experience of the development of drug-device combination products, particularly from a clinical regulatory perspective. Knowledge of global regulatory guidelines, GxPs, local regulations and industry best practices. Ability to understand and interpret clinical data/information and its practical application in regulatory contexts. Experience of technical/regulatory writing (e.g. briefing books, responses to questions, applications for early access schemes, paediatric plans etc). Experience of working with multi-located cross-functional teams including in an outsourcing model using regulatory vendors. Proficient in pertinent software such as Microsoft Office Suite and Adobe Acrobat. Experience across a range of therapeutic areas; experience in psychiatry and/or neurology is a benefit. Experience of the development of scheduled drugs is a benefit. Bachelor’s or advanced degree (MS, PhD or MD) in Life Sciences/Health-Related Sciences Knowledge and Abilities: Strong attention to detail with exceptionally high standards for document and submission quality. Excellent written/oral communication skills. Excellent organisation skills. Team oriented and flexible. Able to manage conflicting priorities. The attitude and ability to be effective in a lean, small company environment in early-stage research biotech business in pre-revenue/profits phase. Ability to embrace and drive change across functions. Energetic, and enthusiastic. An entrepreneurial, business-oriented mindset / strong fit with the team; willing to “roll their sleeves up”. Competencies Technical Capability / Accountability / Decision Making /Communication /Collaboration/Leadership Gerry Kennedy, Managing Director, Recruitment for Technology Ltd. cv to 00 353 87 2834400

Principal Medical Writer, Clinical Development Our client is a Biotech company with a strong pipeline, now wish to hire a Principal Medical Writer within their Clinical Development team, working closely with functional teams e.g. Clinical Operations, Regulatory Affairs, Medical Affairs, Commercial, etc. The successful candidate will author, review and manage clinical documents, e.g., clinical study protocols and/or amendments, investigator brochures, clinical study reports and clinical summaries, and regulatory development documents for FDA, EMA, MHRA, etc. This hire will be based in either Ireland or the UK; with flexibility to work remotely from their own home office, with occasional travel to their office. The ideal candidate will be an experienced Medical / Regulatory Writer, operating at Senior or Principal level,of clinical documents in clinical research, and writing clinical components in regulatory filings (NDA, BLA, MAA) within Pharma / Biotech environment. Responsibilities include: • Liaise with medical/clinical experts, statisticians, investigators, and other relevant stakeholders during document development., • Updating clinical and non-clinical regulatory documents throughout their lifecycle., • Supporting applications to authorities and drafting briefing packages., • Overseeing publications of key guidelines within relevant diseases and support internal training., • Draft literature reviews, abstracts, posters, slide decks, working from various data sources including clinical study reports, protocols, etc., • Coordinate trial team participation in the preparation of such documents, including facilitating meetings, developing and managing timelines, document review, and decisions., • Supporting development of communication material and ensuring company messaging is conveyed in a consistent scientific manner across documents., • Generating templates and ensuring alignment across documents., • Support the development of communication material. Qualification and experience requirements include: • BSc in Life Sciences. Advanced Qualifications preferred i.e. PhD and Post Doctorate work., • 5+ years Pharma / Biotech industry experience, 2 years of which in Regulatory Medical Writer role or similar., • In-depth of knowledge writing or editing clinical trial documents, e.g., Protocols, IBs, CSRs and clinical summaries to ICH GCP and regulatory requirements, • Experience in preparation of clinical components in regulatory filings (NDA, BLA, MAA) is preferred., • Strong analytical skills including good understanding of common statistical methods used in clinical trials and interpretation of their results., • High quality standards and is committed to meet deadlines., • Excellent written and oral communication skill within medical/science area., • Solid ability to perform background literature research., • Excellent English (written and spoken)., • Excellent attention to detail. For further details, please contact Larry on +353 1 – 2302400 / The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. Follow us on Twitter, Facebook and LinkedIn

Investigator – Clinical Trials Role Summary: The Investigator leads and oversees clinical trials at their site, ensuring participant safety, regulatory compliance, and high-quality data collection. They provide medical expertise, guide study teams, and communicate effectively with sponsors, study directors, and site staff. Key Responsibilities: • Provide overall medical direction and review study protocols in line with GCP and investigational plans., • Ensure participant safety, rights, and confidentiality throughout the trial., • Oversee clinical procedures, assessments, and administration of investigational products., • Ensure accurate, complete, and timely data collection; maintain proper documentation and regulatory compliance., • Collaborate with clinical operations, research staff, sponsors, and IRBs, including reporting adverse events and protocol deviations., • Review and monitor protocol adherence, study materials, and investigational product use., • Facilitate monitoring, audits, and inspections by sponsors and regulatory authorities., • Inform participants and IRBs appropriately if the trial is terminated or suspended. Required Skills & Abilities: • Strong knowledge of GCP, regulatory requirements, and biomedical research ethics., • Excellent communication, collaboration, and critical thinking skills., • Attention to detail and dynamic problem-solving capabilities., • Commercial understanding of business operations., • Willingness to travel as required (up to 10%). Education & Experience: • Medical degree recognised by the GMC with an active GMC license., • GCP training and certification., • Board certification or eligibility in a specialty relevant to the research conducted at the site.

Director Biostatistics | Global Pharma | UK | Home Based | Global Pharma recognised for its commitment to innovation and patient impact, is expanding rapidly in the UK. As part of this growth, the company is offering a rare opportunity for a Director Biostatistics to join them. This is an organisation where excellence is not just expected, it’s cultivated. Known for its open, forward-thinking culture and genuine commitment to purpose-driven science, the company provides an environment that inspires, supports, and rewards. Every contribution here matters. Every voice is valued. And every project pushes the boundaries of what’s possible in modern medicine. As a Director Biostatistics you will be joining a cross-functional team that requires strong independent leadership to support clinical and observational studies, medical affairs strategies, biomarker and PK/PD analyses, or regional projects. The Director may also lead statistical efforts for early-stage assets or serve as a methodology expert, ensuring high-quality data analysis and interpretation across a variety of programs. What you will be doing: • Lead statistical strategy for haematology oncology, serving as compound-level statistical lead across development, evidence generation, and regulatory/payer interactions., • Develop integrated statistical strategies across trial phases (early, pivotal, RWE, post-marketing), aligned with product profile and development goals., • Provide cross-functional leadership across clinical, medical affairs, RWE, safety, and biomarker statistics., • Represent the organisation in global regulatory and payer discussions (FDA, EMA, PMDA, HTA), guiding statistical input for submissions and evidence packages., • Act as an individual contributor (no line management) while mentoring study-level statisticians., • Present findings clearly to stakeholders and leadership., • Ensure integrated data availability for submissions and marketing support., • Contribute to due diligence, data review, and expert statistical guidance., • Implement and oversee advanced statistical methods. What you will need: • PhD or Master’s in Biostatistics, Statistics, or related field., • Significant oncology clinical development experience, including regulatory submissions and statistical strategy leadership., • Expertise across trial design, biomarkers, exploratory analytics, RWE, safety, and post-marketing support., • Experience with Bayesian methods, adaptive designs, external control arms, and AI/ML in clinical development., • Knowledge of real-world data sources, integration, and interpretation., • Recognised scientific contributions (publications, presentations, or working groups such as ASCO/ESMO)., • Strong leadership presence in external regulatory/HTA/scientific discussions., • Proficiency in SAS (R preferred), with solid understanding of data management and programming practices., • Experience in international teams and ability to communicate complex methods clearly. What to do next: If this opportunity is of interest, please apply now with your CV or reach out to arrange a confidential discussion about other potential opportunities

We are part of a leading international group of fertility specialists, including CREATE Fertility, ABC IVF, Vitanova and IVI UK, providing world-class reproductive healthcare across the UK. Our clinics are at the forefront of innovation, offering Natural and Mild IVF meaning, gentler, safer approaches that use little to no fertility medication alongside a full range of advanced treatments, including IVF, IUI, ICSI and fertility preservation. Together, we are committed to evidence-based treatments, cutting-edge technology and personalised, patient-focused care helping to give every patient the best possible chance of success. Please note, this role sits within IVI RMA, covering the Northern Europe region ROLE PURPOSE The UK Nurse Director is a key member of the UK Leadership Team, serving as the professional nursing lead across all UK clinics. The UK Nurse Director is responsible for nursing governance, clinical quality, workforce leadership and the implementation of nursing protocols that ensure the highest standards of patient safety and care. The UK Nurse Director is accountable for all nursing processes and KPIs across the UK, including the delivery of safe, effective, patient-centred care and supporting commercially aligned service delivery. This includes line management, development, and performance oversight of nursing teams across the organisation, and close collaboration with Medical Affairs, Operations, HR, and Quality colleagues. KEY RESPONSIBILITIES Reporting to the UK Medical Director, serving as the national nursing lead and key partner to the UK clinical and operational leadership teams, the UK Nurse Director leads all nursing functions to drive consistent standards, regulatory compliance, and service excellence, including but not limited to the following: • Leadership of the national nursing team, including Lead Nurses, Nurse Managers, Fertility Nurses, and other roles introduced as the nursing structure evolves, • Collaboration with Deputy Medical Director and Medical Affairs colleagues on the development, revision, and updating of clinical and nursing protocols, pathways, and strategic projects, • Establishment, control and monitoring of nursing processes in line with Group policies to ensure effectiveness, safety and operational consistency, • Acting as the central representative for the nursing profession in the UK, coordinating communication flows, providing guidance and ensuring nursing alignment across all clinics, • Collaboration with HR and L&D to deliver continuous professional development, internal training and structured competency pathways for all nursing staff, • Leadership in the design, execution and improvement of both clinical and non-clinical processes to reduce patient safety risks and enhance quality of care, • Promotion of a strong safety culture, ensuring nursing teams understand and adhere to patient safety risk management principles, • Identification, documentation, reporting and management of patient safety risks, including implementing required actions instructed by Medical Affairs, • Ensuring full compliance with HFEA, NMC, BFS guidance and other relevant regulatory and professional bodies, • Oversight of clinical success metrics, supporting underperforming nurses through targeted training, one-to-one development, and audit monitoring, • Support for recruitment through CV screening, interviewing and workforce planning, • Collaboration with clinics on equipment training, capital expenditure requests and ensuring appropriate nursing resources are maintained, • Leadership of SOP development updates and implementation, ensuring clinics adopt and deliver all required standards, including training Lead Nurses in SOP compliance, • Active involvement in IVI Group projects, representing the UK in group-wide nursing and clinical initiatives, • Acting as the primary UK contact for data and information requests from Helix or Group functions, • Participation in leadership activities with CMO/COOs to support overall performance improvement across clinics, including involvement in performance or conduct management relating to nursing staff, • Quarterly audit of nursing performance data to support quality reviews and clinical improvement plans, • Contribution to patient pathway optimisation, service efficiency reviews and assessment of workforce capability, resource needs and equipment alignment, • Review of business cases for nursing-related equipment and capital expenditure requests with Finance, • Support for clinic-level complaint resolution, including resolving local complaints with Clinical Directors and managing serious issues with the Quality and Complaints Director, • Development and delivery of complaint-handling training to strengthen nursing team capability EXPERIENCE/PERSONAL SPECIFICATION • Registered Nurse (NMC) with no restrictions, • Significant leadership experience within a regulated healthcare environment, ideally within fertility or women’s health, • Minimum 5 years’ experience working within an IVF unit, • Demonstrable experience implementing clinical protocols, improving patient safety and managing clinical risks, • Proven track record in leading multi-site nursing teams and driving performance improvement, • Experience working with regulatory frameworks including HFEA, NMC, BFS and internal governance structures, • Competence in workforce development, training frameworks and clinical competency assessment, • Strong operational understanding with the ability to support commercial and service efficiency objectives CONFIDENTIALITY The post holder must maintain the confidentiality of information about patients, clients, staff and Create Health Clinics’ business in accordance with the HFEA Code of Practice, the Code of Confidentiality of Personal Health Data, the Korner Report on confidentiality, the Data Protection Act 1998 and Caldecott principals. CONSCIENTIOUS OBJECTION The Human Fertilisation and Embryology Act 1990 specifies that “No person who has a conscientious objection to participating in any activity governed by this Act shall be under any duty, however arising, to do so. In any legal proceedings the burden of proof of conscientious objection shall rest on the person claiming to rely on it.” HEALTH & SAFETY Employees must be aware of the responsibilities placed on them under the Health & Safety at Work Act (1974), to ensure that the agreed safety procedures are carried out to maintain a safe environment for employees and visitors. RISK ENGAGEMENT All staff have a responsibility to report all clinical and non-clinical accidents or incidents promptly and when requested to co-operate with any investigations undertaken. EQUAL OPPORTUNITY Create Health Clinic has adopted an Equal Opportunities Policy and all employees must be aware of their obligations to abide by the spirit and nature of the Policy to avoid direct, and indirect, discrimination. CONFLICT OF INTEREST Create Fertility and IVI RMA is responsible for ensuring that the service provided for patients in its care meet the highest standard. Equally, it is responsible for ensuring that staff do not benefit their family or friends.

About Freyr Freyr is a global Regulatory Solutions and Services organization supporting Life Sciences companies across Regulatory Affairs, Clinical, Safety, and Compliance. We partner with leading pharmaceutical, biotechnology, and medical device companies, delivering end-to-end regulatory operations support and regulatory strategy with precision, speed, and global expertise. Role Overview: Freyr's client is seeking a Regulatory Affairs Manager to fill a critical role in supporting development and execution of global regulatory strategies for investigational submissions, with a focus on EU and UK CTR. This role ensures compliance with regulatory requirements and manages lifecycle activities in alignment with the Global Regulatory Lead (GRL). Job Title: Regulatory Affairs Manager Location: Remote ( United Kingdom ) Job Type: Permanent/Full-Time Key Responsibilities • Provide critical support in developing global regulatory strategy, planning, and execution of global investigational submissions, and manage lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL)., • Work collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to contribute to global regulatory plans, address global regulatory issues, respond to health authority queries, and meet regulatory obligations., • Research and apply regulatory intelligence and knowledge of strategic options to enable innovative regulatory pathways and solutions for complex global requirements and regulatory challenges., • Perform independent QC on prepared CTA submissions, including submission documents and structured data populated within the CTIS and IRAS submission portals., • Act as a liaison while coordinating CTA activities with multidisciplinary teams., • Provide support for preparation, submission, lifecycle management, and archival of CTA submissions and related correspondence., • Assist with the development of assigned regulatory operations work instructions., • Overall knowledge of regulations/guidance supporting EU Clinical Trial Regulation (CTR) and UK The Medicines for Human Use (CTs) (Amendment) (EU Exit) Regulations 2019 (to be replaced by new Clinical Trials Regulations in April 2026)., • Demonstrated performance in managing and producing time-intensive deliverables., • Strong attention to detail in data entry accuracy and in following specific process steps outlined in procedural documents., • Knowledge of Document Management Systems (Documentum-based preferred)., • Recent experience submitting regulatory submissions using Health Authority Portals., • Strong computer skills with proven experience in Microsoft Office (Word, Excel, Access, PowerPoint) and SharePoint. Why Join Freyr Joining Freyr gives you the platform to work on impactful regulatory initiatives across global markets. You will collaborate with experienced regulatory leaders, gain exposure to complex submissions, and contribute to meaningful projects supporting patient safety and global transparency.t. What we Offer: Opportunity to work within a collaborative and growth-driven global regulatory team, cross-functionally supporting innovative clinical trials. • Lead complex CTA submissions while shaping regulatory strategies aligned with EMA, MHRA, and ICH guidelines.