Clinical research jobs in BristolCrear alertas

Senior AI Engineer (Generative AI Consultancy) – Bristol (On-site, Up to 5 days per week) Healthcare • Generative AI • Research & Innovation £90,000 - £130,000 (DOE) opportunity to shape industry-defining work Are you an experienced AI professional ready to help define the future of healthcare? I’m supporting a rapidly scaling organisation that has just opened a brand-new Bristol office and is now hiring three Senior AI Engineers to join their growing team. This is an exceptional opportunity to work on cutting-edge Generative AI projects that are currently in the research phase and have the potential to shape the next generation of healthcare technology. Due to NDAs, full project details will be shared during an initial conversation — but expect complex, meaningful, and highly innovative AI challenges. What they’re looking for: 7–8 years’ commercial experience in AI / Machine Learning Strong hands-on expertise in Generative AI (LLMs, multimodal models, RAG, diffusion models, or similar) Solid background in healthcare – NHS, medtech, clinical data, medical devices, or regulated environments Ability to demonstrate the evolution of AI technologies you’ve worked with Experience building or contributing to AI-driven automation or intelligent systems Someone who thrives in a collaborative, research-focused environment Location Requirements: Must be Bristol-based Happy to work on-site up to 5 days per week (A brand-new office designed for high-collaboration projects) The Interview Process: A straightforward 3-stage process (with a potential additional conversation if needed, but very rare). Why join? • Work on groundbreaking GenAI use cases with real-world impact, • Join at an early stage and help shape the direction of the AI team, • Collaborate with senior specialists across Europe, • Be part of a company investing heavily in innovation and research If you’re Bristol-based, experienced in Generative AI, and passionate about transforming healthcare through cutting-edge technology, I’d love to hear from you. Apply or message me for an informal chat.

Job Title: Nurse – Clinical Research Location: Bristol Contract Length: Ad-hoc days over the next 3 months Rate: £30-£35/hour plus expenses Clinical Research Nurse – Bristol Are you a passionate nurse looking to make a real impact in clinical research? Our client is seeking three Clinical Research Nurses to join a groundbreaking Phase III flu vaccine study. This is your chance to be part of vital work that will shape the future of healthcare while enjoying competitive pay and flexibility across Bristol. About Our Client Our client is a leader in patient‑centric, decentralised clinical trials. Since 2008, they’ve been redefining how research is delivered, ensuring patients can participate in ways that fit their lives. With rapid expansion across Europe, they’re offering nurses the opportunity to be at the forefront of innovation in clinical research. The Role As a Clinical Research Nurse, you’ll play a key role in delivering safe, high‑quality care to participants aged 12+. You’ll be based across Bristol and may support multiple locations depending on availability. 📌 Key Responsibilities • Provide exceptional nursing care to study participants aged 12+, • Perform venepuncture, LPA procedures, and infusion administration with confidence, • Ensure compliance with study protocols and safeguarding standards, • Maintain accurate documentation and uphold regulatory requirements, • Work collaboratively with clinicians and research teams to deliver a seamless patient experience 🎯 Skills & Experience • NMC Registered Nurse (Paediatric PIN preferred; RGNs considered with paediatric experience), • Competency in venepuncture, LPA, and infusion administration (including port access), • Enhanced DBS check on the Update Service strongly preferred (or certificate issued within 12 months), • Up‑to‑date IV passport, paediatric BLS (in‑person preferred), and safeguarding training, • Organised, adaptable, and able to manage multiple site visits and patient schedules Interested? Apply now for immediate consideration or contact James Allen on +44 203 868 8607 – We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Business providing Global Staffing services.

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.

Senior AI Engineer, Healthcare (Agentic AI), Remote or Hybrid, €80k to €100k plus equity Are you an experienced AI Engineer with a track record of shipping production code in startups? Do you want to work on AI that directly improves how healthcare is delivered? Imagine clinics and hospitals running on AI agents that cut admin time and let doctors focus on patients. That is exactly what this ambitious young startup is building. Who are they They’re a venture-backed AI startup with deep roots in both medicine and AI research. Founded by a former Meta Brain team engineer and a medical specialist, they’ve already launched agentic AI products into live clinics and are now scaling up to production. They raised funding late last year, kept the team lean, and are now ready to expand. The team currently includes a CTO, an AI Engineer and a Junior Engineer, with strong support from top-tier VCs and angels. They’re looking for two Senior AI Engineers to help build secure, scalable, compliant AI systems that integrate with clinical workflows. With plans to raise their next round in Q3 2026, you’ll be joining at a pivotal moment where your impact will shape the company’s trajectory. What are we looking for The ideal candidate is a strong communicator who can work independently and bring real depth on the infrastructure and deployment side. You should be able to separate noise from signal, evaluate information quickly and explain your thinking clearly. Most importantly, you prioritise business value over building tech for the sake of it. You will have • 5 plus years building and deploying production systems in startups or fast paced environments, • Strong Python coding experience, • Experience with Azure or GCP, • Knowledge of distributed systems, microservices and event driven architectures, • Solid system design and security principles You will stand out if you • Have strong communication skills and can explain technical decisions clearly, • Can work independently and manage uncertainty in an early stage environment, • Are strong on the infrastructure and deployment side, • Can separate noise from signal and evaluate information quickly, • Focus on business value rather than building tech for the sake of it Bonus points for • AI or ML production experience including MLOps and model deployment, • Go, Docker, Kubernetes, infra as code, • Experience with healthcare standards such as FHIR, HL7 and DICOM What you will get • €80k to €100k base salary, with equity available for exceptional candidates, • Fully remote setup, with the option to work from Germany if you prefer, • The chance to build mission critical AI in healthcare and see your work used by clinicians and patients Interested If you are excited by building agentic AI in one of the highest stakes industries, hit apply now or reach out directly: Email: Call: 02037736498

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.

• Job Title: Senior Clinical Research Associate (Oncology), • Location: UK, Remote, • Other Details: Full-Time | Permanent | Small CRO, • Salary: Up to £65,000 (DOE) Are you an experienced CRA with a strong background in oncology trials? A small, agile CRO is seeking a Senior Clinical Research Associate to join their growing team. This is a home-based role with national travel, where half the sites are based in London. Key Responsibilities • Monitor Phase I–III oncology clinical trials across UK sites., • Conduct site visits (approx. 6–7 days/month) ensuring compliance with ICH-GCP and regulatory requirements., • Manage 1–3 studies concurrently, overseeing 4–7 sites located in London, Manchester, Glasgow, Liverpool, Sheffield, and Cardiff., • Apply RECIST criteria confidently in oncology assessments., • Collaborate with cross-functional teams to ensure high-quality data collection and trial conduct. Candidate Profile • Experience: Minimum 4 years of on-site monitoring as a CRA, with a strong track record in oncology (Phase I–III)., • Education: Bachelor’s degree (BSc, BA, or RN equivalent) in a life sciences or related field., • In-depth knowledge of ICH-GCP and regulatory guidelines., • Location: Must be based within 1 hour of a major airport or railway station. Preference for candidates located in or near London due to site distribution., • Travel: Up to 70% travel across the UK; valid driver’s license and passport preferred. To apply: Please click ‘apply’ or contact Joe Pearce for any further information About RBW Consulting RBW Consulting is a life sciences talent & strategic consultancy with purpose, delivered through what we call Human Intelligence. We help life sciences businesses change the world by giving them the people, insight & networks to innovate and scale. We are proud of our role in helping companies deliver better health and wellbeing outcomes for patients We give back by playing an active role in funding initiatives that change lives We’ve created a culture rooted in support, transparency and mutual commitment. We lead with our values from the inside; empowering and investing in our people is more important than short-term commercial gain. We are an equal opportunities Recruitment Business and Agency RBW Consulting is an equal opportunity workplace. We prioritize talent (both current and potential) over resumes, challenge the status quo, and value people as our most important asset. We do not discriminate on the basis of race, ethnicity, colour, sex, gender identity or expression, sexual orientation, religion, age, marital status, visible or invisible disability, medical condition, national origin, veteran status, or any other protected status. We strive to be a diverse workforce that is representative at all levels and are committed to building a team that represents a variety of backgrounds, perspectives, and skills.

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.

Company profile For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Job description ProPharma is currently supporting a development organisation in the Biological space with support for their early phase (phase 1) Clinical trial activities within the EU. This project is to lead as a ‘Freelance Clinical Trial Project Manager’ where the key responsibility would be to manage the CRO tasked with the trial and all associated groups to ensure the success of the project. This assignment requires full time availability (1.0FTE); it can be performed remotely ideally within the EU (the UK is also possible) and it will last for a duration of 6 months with a start date of January 2026 being preferred. Responsibilities included: • Ensure patients within the trials follow all protocols set out (dosed), • Full management of the CRO partners throughout the project, • Effective coordination on a cross-functional basis which includes Regulatory, Quality, Supply Chain etc., • Ensure compliance throughout the project to all necessary guidelines, • Manage key stakeholders throughout the project, • Able to consider all avenues affecting the success of the project and devise solutions to any bottlenecks found, • Ensure the overall success of the project as a key project leader Skills required • Must be educated within a life science discipline to at least a BSc or higher, • Proven experience working as a Clinical Project Manager or higher is a must, • Ideally skilled in the Biological space with Gene therapy exposure being of particular interest, • Must demonstrate key experience managing CRO partners; working on early phase activities (Phase 1) all within the UK/EU, • Fluency in English is a must, • Can perform the project as set out within the job description Additional Information We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

Epidemiologist 12m, remote/hybrid Key responsibilities: • Improve disease understanding relevant to drug development: incidence, prevalence, risk factors, natural history course, treatment patterns, comorbidities, co-medications, outcome measures, phenotypes, biomarkers, unmet needs, and their variations across domains such as demographics and geographies., • Support clinical trial design, in particular identification of the target population, protocol development, patient recruitment and patient medical history data ascertainment., • Contribute to medication safety evaluation: provide background event rates, synthesize existing evidence including through meta-analyses, identify high-risk populations., • Support post-marketing surveillance activities: risk evaluation mitigation strategies, epidemiology studies for signal detection and inference, post-authorization studies of treatment benefit and risk., • Critically appraise existing epidemiology evidence and create new evidence through delivery of specific research plans/protocols and analysis of healthcare databases available within. Experience required: • 5 years or more in Epidemiology in the pharmaceutical industry or equivalent experience in an academic or government setting., • Significant experience applying epidemiologic methods to study a variety of questions in support of medicine development (safety, effectiveness, natural history of disease), • Demonstrable experience leading pharmaco-epidemiologic research programs in a drug development environment and use of real world data (EMR or claims), • Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence to peers and at scientific meetings., • PhD required in epidemiology or a relevant discipline (i.e. health services research, health outcomes research, public health, statistics or pharmaceutical sciences)

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.

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.

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

Consultant in IVF Location: London, Manchester, Birmingham, Kent, Nottingham, Oxford Contract: Permanent | Full-time Are you an experienced IVF Consultant looking to take the next step in your career? Our client, a large national IVF provider is looking for IVF Consultants to join their team in the above locations. What You’ll Do: • Provide clinical services in the field of reproductive medicine as part of a multidisciplinary team. You will be responsible for ensuring that the highest standards of clinical care are delivered in line with company objectives as well as national standards., • You will work closely with the Medical Director, the medical community of the organisation and the wider multidisciplinary team to provide standardised practice across the organisation in addition to continually striving to improve and develop services further. They will be expected to actively participate in clinical governance and quality management of the local service., • The post-holder will work with the Medical Director and colleagues in the management of the rota to ensure activity is achieved and consistent safe cover is available., • You will carry out your roles in a way that supports and delivers through our shared values of compassion, collaboration, and expertise. What We’re Looking For: • Experienced Consultant/Associate Specialist who has worked in the UK., • MRCOG., • In-depth demonstratable experience in IVF with successful outcomes. Why Join? You’ll be part of a pioneering team in fertility care with access to cutting-edge treatments, continuous professional development, and the opportunity to transform lives truly. Benefits: • 33 Days annual leave (inc. 8 public holidays), • Clinical development framework, • Level 3, 5 and 7 leadership apprenticeships, • Research opportunities To register your interest in this role or to find out more, don't hesitate to get in touch with Chris Hemming: 0203 910 0570

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

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India. The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I – IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials. We are currently looking for an enthusiastic and talented Senior Medical Writer for a client dedicated opportunity. This role is home-based in the UK or EU, or office-based/hybrid in Denmark and Sweden. The successful candidate will be overall responsibility for coordinating and managing medical writing tasks, including timely delivery of high-quality documents in accordance with agreements made between Aixial and sponsor. Key medical writing tasks include clinical study reports, Investigator’s Brochure (IB) updates, protocols, as well as summary documents and clinical overviews for submission to regulatory authorities. The candidate will be expected to work in alignment with company values and in compliance with ICH-GCP, national and international regulations and the client’s quality system. They must provide timely feedback to management on work progress and actively participate in scheduled training sessions and required reading. Other medical writing tasks may be assigned as needed. Aixial offers a friendly and stimulating work environment, with ample opportunities for professional growth. Qualifications • Advanced degree in life science, • Preferably 5 – 10 years of relevant medical writing experience, • Ability to structure and plan own work according to agreed timelines, • Excellent attention to detail combined with an understanding of the document’s overall purpose, • Ability to work simultaneously on more than one project, • Ability to establish and maintain effective working relationships with co-workers, managers and clients, • Knowledge of GCP as well as relevant ICH guidelines Technical skills Good knowledge of Microsoft Office 365. Experience with Veeva and PleaseReview is a plus. Languages The job holder will need to be fluent in spoken and written English. For more information on Aixial Group recruitment and consideration for other opportunities, please review the recruitment statement on our careers page ___ Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by Aixial Group Talent Acquisition. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.

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.___

A healthcare organization within the clinical research sector is seeking a Senior Manager to lead the operational and strategic oversight of partnered research sites. This role is responsible for ensuring high-quality execution, regulatory compliance, and strong performance across a multi-site research environment. Responsibilities • Own and manage clinical research site partnerships end to end, • Lead site onboarding and ongoing operational optimization, • Build strong relationships with site leaders, sponsors, and internal teams, • Oversee budgets, contracts, and financial performance, • Ensure compliance with ICH-GCP, regulations, and audit readiness, • Monitor KPIs and drive operational improvements, • Line manage and develop site-based teams, • Bachelor’s degree in a science-related field or equivalent experience, • 6+ years of clinical research experience; 3+ years in leadership, • Strong knowledge of site operations and trial delivery, • Experience with CTMS platforms preferred

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.

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.

• Job Title: Lead Clinical Research Associate, • Location: Remote in UK, • Salary: £56,000 - £63,000 (DOE), • Additional Benefits: Car allowance (or company car) and bonus, • Sign-on Bonus: Potential sign-on bonus for qualified candidates, • Company: Global CRO RBW Consulting is thrilled to present an exciting opportunity on behalf of one of our esteemed clients. As one of the few rapidly growing Contract Research Organizations (CROs) for UK studies, our client is expanding their site management team with multiple hires this year. They are involved in a diverse range of studies, including cutting-edge research in advanced therapies such as CAR-T. Join a highly experienced team dedicated to excellence in clinical research. In this role, you will benefit from a supportive management team committed to your professional growth. They provide clear guidance on the skills needed for advancement and offer fluid career development opportunities across various departments. This company prioritizes quality over metrics and is currently generating significant excitement within their UK team. Key accountabilities • Autonomy of investigator sites with full responsibility for the successful management of sites through study life cycle (start-up to close-out);, • Conduct feasibility, pre-study, initiation, monitoring, and closeout visits for research sites, mainly phase 1 to 3 and within all available therapeutic areas;, • Prepare accordingly and attend investigator meetings, coordinating timely delivery and subsequent proper storage and accountability of clinical supplies and following-up of drug safety issues;, • Perform source document verification and case report form review;, • Perform regulatory document review;, • Conduct study drug inventory;, • Perform adverse event and serious adverse event reporting and follow-up; and, • Assess patient recruitment and retention. Qualifications • Bachelor of Science in health-related field (or equivalent), • Proven CRA experience; 5 years minimum Why Join? • Supportive Environment: Build strong relationships with a transparent management team focused on your development., • Innovative Approach: Work with a company that embraces a 360 monitoring approach and leverages AI to enhance efficiency and save time., • Results-Driven KPIs: Our client's key performance indicators are centered around tangible study outcomes, such as patient recruitment, visit reports, and resolving site issues., • Administrative Support: Dedicated admin staff to help with site management tasks, helping to maintain a balanced workload., • Training: Extensive training and buddy system in place., • Career Growth: promotion opportunities up to 4 times a year., • Therapy Areas: Access to mixed therapy areas, including advanced therapies like CAR-T. To apply Please click ‘apply’ or contact Joe Pearce for any further information About RBW Consulting RBW Consulting is a life sciences talent & strategic consultancy with purpose, delivered through what we call Human Intelligence. We help life sciences businesses change the world by giving them the people, insight & networks to innovate and scale. We are proud of our role in helping companies deliver better health and wellbeing outcomes for patients We give back by playing an active role in funding initiatives that change lives We’ve created a culture rooted in support, transparency and mutual commitment. We lead with our values from the inside; empowering and investing in our people is more important than short-term commercial gain. We are an equal opportunities Recruitment Business and Agency RBW Consulting is an equal opportunity workplace. We prioritize talent (both current and potential) over resumes, challenge the status quo, and value people as our most important asset. We do not discriminate on the basis of race, ethnicity, colour, sex, gender identity or expression, sexual orientation, religion, age, marital status, visible or invisible disability, medical condition, national origin, veteran status, or any other protected status. We strive to be a diverse workforce that is representative at all levels and are committed to building a team that represents a variety of backgrounds, perspectives, and skills.

Shape Your Career with TMC – Emergency Radiologist Opportunity | Relocation Opportunity to Australia, New Zealand or Japan. Join Europe’s leading tele-radiology network and redefine your work-life balance while delivering world-class diagnostics from Australia. At Telemedicine Clinic (TMC), a Unilabs company, they empower radiologists to thrive professionally while enjoying unmatched flexibility and support. To expand their team, we are searching for emergency radiologists eligible to work in Sweden, Denmark, or United Kingdom to relocate to Australia, for a minimum of 12 to 24 months. Japan for 3 or 6 months, or New Zealand for a minimum 12 months. The TMC emergency radiologist will be part of the Emergency section. This section aims to deliver high-quality radiological diagnostic services to our healthcare clients and the patients in a timespan of a maximum 1 hour, or less in case of stroke cases. Why Join Us? • The opportunity to work from Australia, Japan or New Zealand., • Competitive pay with attractive additional income, • Become a sub-specialist in Emergency Radiology, • Access cutting-edge AI tools and our proprietary RIS for efficient reporting (TMC is one of the leading adopters of AI in Europe), • Join a supportive international community of expert radiologists, • 24/7 IT support and a full home workstation provided, if not reporting from the office, • Free access to TMC-Unilabs Academy for CME-accredited training and fellowships (over 250 hours of free education), • Opportunities for leadership, teaching, and research roles, • Strong clinical governance and quality assurance through internal/external audits, • Visas paid for and done by TMC, as well as relocation costs covered What We’re Looking For • Medical doctor with a specialist degree in diagnostic radiology, • Minimum 1 year as a Consultant Radiologist, • Registration with Swedish, Danish, Norwegian or UK medical authorities (or eligibility to obtain it), • Ability to report in the language of at least one of those countries, • Proficiency in English (our corporate language), • Comfortable with digital tools and reporting systems, • Proactive, organised, and solution-oriented mindset, • Strong communication skills

Precision for Medicine is hiring a Medical Director/Senior Medical Director – Oncology to join our global team! candidates can work remotely in any of the following locations: UK, Poland, Hungary, Romania, Serbia or Slovakia. Position Summary The Medical Director serves as the project physician and provides medical and scientific expertise to project teams. The Medical Director’s primary focus of work will be to ensure the accuracy and integrity of the data resulting from the trial, with concentrated focus on patient safety. This position also participates in the strategic planning and execution of critical development programs for a variety of clients in Oncology/Haematology contributes to the development of Precision’s Medical team and supports Business Development activities. Essential functions of the job include but are not limited to: • Work closely with senior leaders in Medical, Operational Strategy, and Business Development to support client engagement., • Support Business Development and Proposals teams by participating in the RFP process; prepare medical considerations section for proposals; and support or participate in bid defense meetings., • Write or edit scientific content of deliverables within budget and timelines., • Collaborates with Regulatory Affairs on regulatory product landscape and strategies as a part of overall drug development strategy., • Provide scientific insight and create content for specified company releases (e.g., white papers and publication manuscripts)., • Review and revise protocols, case report forms, training materials, project specific tools, analysis plans, study designs, clinical trial reports and new drug applications., • Review laboratory values, adverse events, coded adverse event and medication data, and data tables, listings and figures as needed., • Serve as a medical resource for study sites, the project team and clients., • Assist in the preparation of the Medical Monitoring Plan and materials for investigator meetings and staff training sessions., • Assume responsibility for medical and safety monitoring on assigned projects., • Participate in feasibility discussions relating to specific project proposals., • Develop training modules and provide training concentrating on disease states., • Participate in process improvement activities., • Collaborate with Vice President, Global Medical and other members of the Medical Science Department to support growth and development activities globally. Qualifications Minimum Required: • MD, DO, MBBS, or equivalent medical qualifications., • 5+ years of Oncology clinical experience., • Ability to strategically analyze oncology clinical trial protocols., • Availability for domestic and international travel including overnight stays (approximate 30% travel requirement). Preferred • Experience working as a Medical Director for a CRO or Pharmaceutical company., • Oncology Fellowship or equivalent., • Maintains current scientific and medical knowledge base. Skills/Competencies • Ability to deliver on commitments; understands the service culture., • Strategic thinker who can build strategic drug development solutions associated with novel development programs, study designs, and patient populations., • Demonstrates a high degree of professionalism, as evidenced by punctuality, positive interactions with customers and teammates, including good interpersonal skills., • Communicate effectively in the English language both verbally and in a written form., • Conduct formal presentations to a wide variety of audiences including colleagues., • Strong visual and presentation skills., • Ability to work effectively in a fast-pacing team setting, with minimal supervision., • Proven efficiency in working remotely. Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. Any data provided as a part of this application will be stored in accordance with our ___ For CA applicants, please also refer to our ___. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at . It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

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!

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.

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 DESCRIPTION Supports, implements, and follows all hospital, departmental and divisional initiatives, policies and procedures Helps lead and implement the organization’s performance management system, including peer review and the productivity and utilization review processes Participates in the organization’s performance management system, including peer review and the productivity and utilization review processes Assists with scheduling and supports the Division Chief in ensuring that adequate medical coverage is provided within the Division at all times Attends Divisional meetings as required Assists the Division Chief in the recruitment of new medical staff when appropriate Assumes other administrative or clinical duties as requested by the Division Chief Technical Diagnoses And Treats Patients According To Established Standards Of Best Practice For The Post Holder’s Specialty. The Consultant Physician’s Clinical Duties Include But Are Not Limited To The Following: • Oversees the clinical activities of the junior medical staff and is assumes responsibility for the care they provide, • Complies with all established hospital polices regarding admissions, consultations, daily patient care, surgical procedures, discharge protocols, outpatient and follow up practices, • Practices appropriate utilization of the organization’s resources, • Leads ward round; reassesses both inpatients and outpatients on a regular basis, in line with established best practice, • Accurately documents all relevant clinical information in a clear and timely fashion in accordance with established procedures, • Regularly reviews results of all investigations and modifies treatment as required, • Liaises with other medical specialties and support services for additional input as required, • Actively participates in multi-disciplinary meetings to help plan effective, safe and holistic care for individual patients, • Ensures preparation of patients for all procedures including obtaining informed consent, • Accepts clinically appropriate referrals from the Emergency Department, primary care, other departments, specialty clinics, walk in patients, and patients referred from other hospitals, • Participates in and ensures the provision of out of hours (on call) coverage on a rotational basis including evenings, nights, weekends and public holidays as required, • Communicates clinical information to patients and the patient’s family and friends (with consent of the patient) in a timely manner, • Maintains a good working relationship with members of staff and promotes collaboration and a team-based approach to patient care Helps lead quality improvement within the Department Supports a culture of regular audit and encourages the use of audit results for improving clinical practice Supports the reporting, investigation, and response to untoward incidents Education Fosters a culture of learning, development and continuous improvement across the Department by: • Promoting and assisting in the instruction, guidance and supervision of junior medical staff (required), • Facilitating the provision of essential training relevant to clinical staff in the specialty Keeps abreast of the current, relevant literature and the latest trends and technologies in the industry Facility specific Responsibilities of the role Corresponding Activities performed by the role SEHA Compliance guidelines Corresponding Activities performed by the role Complying with Policies, Procedures and Practices of the SEHA facilities and other regulatory requirements Complying consistently with facility policies, procedures and practices and ensuring alignment with SEHA facilities policies Completing and maintaining regulatory requirements including: licensure and certification and other mandatory training within established time frames Maintaining Confidentiality Maintaining confidentiality with regards to any information exchanged or received in the current capacity of role in accordance with facility policy Promoting Customer Service standards Assuming the role of a brand ambassador for the facility and promoting a customer focused philosophy in dealing with any stakeholders Maintaining positive and effective working relationships within the department/division and also with other departments/sections within the facility Performing any other duties as may be assigned relevant to the basic responsibilities of the role Adhering to the Occupational Health and Safety, Materials Management and Maintenance standards Adhering to requirements of the Occupational Health and safety guidelines and infection control guidelines Understanding and adhering to emergency preparedness plans/policies Ensuring Personal Effectiveness Recognizing the necessity of continuously developing skills and acquiring additional knowledge appropriate to the position Dressing appropriately to meet the expectations of the specific work area and in alignment with the Occupational Health and Safety policies Building key partnerships within the organization for pursuing client-centered, comprehensive, integrated systems of care Complying with any regulations related to mentoring, training and development of UAE nationals staff Qualifications, Certifications and Experience Required: • Qualification from Tier 2, • Current national license or equivalent, • Certified proof of yearly CME Additional Qualifications: • Medical Degree (MBBS or equivalent) and specialization in Dermatology, • American Board, CCT UK, Australian Board, any Western Board, Fellowship or additional certification in Dermatology/ Pediatric Dermatology, • Minimum of 5 years of post-specialization experience in Dermatology, • Valid DOH (Department of Health - Abu Dhabi) License or eligibility.

Company profile For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Job description ProPharma is continuing to be an integral partner of a global life-sciences brand as they require project support within their Regulatory Affairs group within the EU. This role in particular is to act as a Regulatory Affairs Project for their Clinical trial applications (CTA’s) within the EU space with demonstrated experience in the area being a must. The project will commence in January 2026; it is a full-time position (1.0 FTE) and can be performed fully remotely throughout anyway within the UK or EU. It will run for at least 6 months initially but with a high chance of extending and we would prefer support from an independent consultant. Responsibilities included: • Provide guidance and support as a project leader on a cross functional basis within the Regulatory Affairs CTA group, • Work effectively with various stakeholders to ensure each projects success, • Lead the preparation, review and submit regulatory clinical trial applications within the EU, • Ensure all submission activities meet key regulations within the region, • Ensure compliance is achieved to the EU CTR regulations throughout each project, • Implement and submit key documentation on to our clients systems, • Provide key project leadership across a range of groups, • Ensure all timelines and milestones are achieved throughout the project, • Overall support our client with strategic and operational goals within the Regulatory Affairs CTA space Skills required • Must be educated within a life science discipline to at least a BSc or higher, • Proven experience working within Regulatory Affairs linked to Clinical trial applications is a must, • Can demonstrate key project management skills within a similar setting, • Thorough experience working to all key regulations within the EU, • Strategic and operational skills within the area are a must, • Fluency in English is a must, • Can perform the project to the requirements set out within the job description #LI-DNI Additional Information We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

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:

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.

Lead Physician – London Overview An exciting opportunity is available for a senior medical professional to take a leadership role in the delivery of clinical trials involving various Therapy area's. The position is ideal for someone with prior Principal Investigator experience and a strong interest in mental health innovation. You’ll be working across dynamic, multi-disciplinary teams, guiding trials from early phases through to completion, while maintaining the highest standards in clinical care, compliance, and operational delivery. Role Focus The successful candidate will be responsible for safeguarding participant wellbeing, ensuring trial integrity, and upholding compliance with all relevant clinical regulations and best practices. In this role, you’ll help shape the future of research in an evolving area of mental health treatment. Key Duties and Responsibilities • Take full responsibility for the medical conduct of clinical studies as the lead investigator, • Ensure all research activities comply with Good Clinical Practice (GCP) guidelines and regulatory standards, • Conduct eligibility assessments, safety evaluations, and clinical reviews throughout the study lifecycle, • Make appropriate clinical decisions regarding patient inclusion, dosing readiness, and follow-up care, • Supervise the reporting of any adverse or serious adverse events and ensure timely communication with relevant oversight bodies, • Mentor and support clinical teams involved in research delivery, providing ongoing guidance and medical input, • Collaborate effectively with operational teams, sponsors, and external research partners, • Review and sign off on essential clinical documentation, including source notes and trial case report forms, • Oversee the use, control, and accountability of investigational products and other study-related medications, • Monitor the collection and quality of structured clinical assessments and psychiatric rating scales, • Keep up to date with developments in psychedelic research and relevant clinical guidelines Skills and Experience Required • Medical qualification with active professional registration and licence to practise, • Specialist accreditation or membership (e.g., psychiatry, internal medicine, or similar), • Prior experience acting as Principal Investigator on clinical trials, • Solid understanding of regulatory frameworks including GCP, FDA, EMA, and other global standards, • Previous involvement in psychiatric or CNS-focused studies preferred, • Confident in managing clinical risk and making sound medical decisions, • Proficient in clinical assessments and familiar with tools such as MINI, CAPS-5, or C-SSRS, • Strong communicator, capable of working with diverse teams and external stakeholders, • Comfortable with oversight of investigational products and protocol compliance

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.

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Clinical Research Associate (CRA) / Site Manager – Europe (UK-based). Clinical Research Associate (CRA). Clinical Research & Medical Tech Experience.

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