Clinical Project Manager
hace 7 días
Welwyn Garden City
As an ISO 9001-certified organisation, PHARMExcel delivers high-quality, results-driven clinical services across non-interventional studies, CTIMPs, ATMPs, rare disease programmes and medical device investigations. We partner with leading experts, world-class academics and innovative biotech and medtech entrepreneurs to support research that makes a real difference to patients’ lives. As a valued member of the Clinical Operations team, you will play a key role in delivering high-quality clinical studies and supporting the continued growth and success of PHARMExcel. You will provide leadership, operational oversight and expert guidance across a diverse portfolio of clinical research projects. Your contributions will ensure studies are delivered on time, within budget, and to the highest standards of quality, compliance and client satisfaction. As a subject matter expert, you will be providing guidance and support to colleagues while helping to drive operational excellence and continuous improvement across the business. We are looking for someone who combines strong technical expertise with outstanding relationship-building, communication and organisational skills. You will be confident developing trusted partnerships with sponsors, investigators, vendors and internal teams, bringing people together to solve challenges, maintain momentum and ensure studies are delivered successfully and on schedule. As a growing CRO, we can offer a breadth of experience that is often harder to find in larger organisations. You will enjoy a varied role with exposure to all aspects of clinical project management, working closely with clients and stakeholders and taking ownership across the full study lifecycle. This broader scope offers excellent opportunities to develop your skills and experience. We are proud of the supportive culture we have built at PHARMExcel. People are generous with their time, knowledge and support, working together to overcome challenges and celebrate successes. We are looking for someone who shares that collaborative, positive and solutions-focused approach and would enjoy being part of our team. You will: • lead the delivery of clinical studies from start-up through to close-out, ensuring quality, compliance and operational excellence, • build trusted relationships with clients, sponsors, investigators, vendors and study teams, acting as a key point of contact throughout the study lifecycle, • provide expert guidance on clinical operations, research governance and regulatory requirements, • contribute to protocol development, ethics and regulatory submissions, and study documentation, • oversee project activities, proactively managing risks, resolving challenges and driving study delivery to ensure key milestones are achieved, • coordinate cross-functional teams and external stakeholders to maintain momentum, drive accountability and minimise delays, • monitor study progress against timelines, budgets and objectives, taking appropriate action to keep projects on track, • support operational excellence and continuous improvement initiatives to enhance quality, efficiency and client satisfaction This is a remote first role, offering flexibility to work from home while being part of a supportive and collaborative team. We come together at least quarterly at our Head Office in Welwyn Garden City for team days focused on collaboration, learning and sharing ideas. Occasional travel to trial sites will be required to support assigned studies. • drive continuous improvements to enhance quality, efficiency and operational excellence across assigned studies., • take ownership of the financial performance of assigned projects, ensuring delivery within agreed budgets and timelines., • build strong relationships with clients, sponsors, investigators and study teams to support successful project delivery and high levels of client satisfaction., • prepare and deliver project communications, updates and reports to clients, sponsors and investigational sites., • organise and coordinate study meetings, investigator meetings and other project-related activities as required., • manage competing priorities effectively, ensuring key deliverables are completed within agreed timelines., • lead the development, review and finalisation of clinical study protocols and other key study documentation., • prepare or oversee Ethics Committee (EC), Competent Authority (CA) and other applicable regulatory submissions., • work closely with Clinical Research Assistants and other colleagues to ensure study documentation is maintained and distributed appropriately., • support monitoring and study close-out activities, ensuring studies are delivered to the highest standards of quality, compliance and governance., • contribute to a positive team culture that encourages collaboration, innovation, continuous improvement and personal accountability. We are looking for someone who is proactive, organised and solutions-focused, with the experience and confidence to lead complex clinical studies and build strong relationships with clients and study teams. You will bring: • 5+ years’ experience in a clinical operations role within a pharmaceutical company, biotechnology company or CRO, including responsibility for the delivery or oversight of international clinical studies., • strong working knowledge of clinical operations, study management, clinical site activities and monitoring processes across the clinical trial lifecycle., • proven experience delivering complex clinical studies, balancing quality, timelines, budgets and stakeholder expectations., • proven ability to develop trusted, long-term relationships with sponsors, vendors and cross-functional teams, acting as a key partner throughout the study lifecycle., • Able to influence stakeholders, drive accountability, coordinate activities across multiple parties and proactively manage risks to ensure studies progress smoothly and milestones are achieved without unnecessary delays., • excellent understanding of ICH-GCP, applicable regulatory requirements and research governance processes., • ability to identify risks, solve problems and make informed decisions in a dynamic clinical research environment., • strong organisational skills, with the ability to manage multiple priorities and deliver high-quality work to agreed timelines., • excellent communication, report-writing and stakeholder management skills, with a high level of attention to detail. Must have: • right to work in the UK, • a full UK driving licence, • a collaborative approach and commitment to teamwork, • passion for clinical research and making a difference, • integrity and professionalism in everything you do, • a strong commitment to quality and delivering high standards Nice to have: • experience in early phase clinical research and/or oncology studies, • familiarity with ISO 14155 and medical device regulations, • experience across CTIMPs, medical devices, ATMPs or non-interventional studies, • knowledge of ISO 9001 quality management systems, • previous mentoring or coaching experience, • a project management or clinical research qualification What you will receive: • Competitive salary (DOE), • Generous annual leave + your birthday off, • Private medical insurance, • Company bonus (performance-based), • Remote-first culture with flexible working, • Family-friendly policies & travel incentives, • Professional memberships paid for, • 24/7 confidential Employee Assistance Programme (EAP), • Wellbeing, ESG, and charity initiatives, • Supportive and collaborative work culture PHARMExcel is a growing CRO built on teamwork, integrity, quality and passion. We invest in our people, foster a supportive and collaborative environment, and provide opportunities to make a meaningful contribution to high-quality clinical research. We value the ideas, expertise and contributions our people bring, encourage continuous learning and development, and support one another to achieve shared goals. You will be part of a welcoming team committed to delivering exceptional research and making a meaningful difference for clients and patients alike. Equal opportunity statement At PHARMExcel, we believe that people do their best work when they feel valued, respected and supported. We are committed to creating an inclusive workplace where everyone feels welcome, can be themselves, and has the opportunity to thrive. We welcome applications from all suitably qualified candidates and do not discriminate on the grounds of sex, sexual orientation, marriage or civil partnership, pregnancy or maternity, gender reassignment, race, colour, nationality, ethnic or national origin, religion or belief, disability, or age. We judge people on their skills, experience and contribution, and we have a zero-tolerance approach to discrimination, bullying and harassment of any kind. We are committed to making our recruitment process as accessible and inclusive as possible. If you require any reasonable adjustments as part of your application or during the recruitment process, please include details in your cover letter so that we can discuss and accommodate your requirements appropriately. #J-18808-Ljbffr
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