- Lead the country strategy for study start-up. Drive efficiency and work well with stakeholders.
- Oversee start-up operations. Make sure sites open on time and stay compliant.
- Lead UK clinical trial submissions, such as HRA, Ethics and MHRA. Manage amendments as studies progress.
- Oversee Informed Consent Forms, from preparation to submission and archiving.
- Plan and manage site budgets and contracts, including using the interactive costing tool (iCT).
- Liaise with bodies like Ethics Boards and Health Authorities on trial policies.
Your Background:
- A life sciences degree or equivalent. A postgraduate or master's degree is a bonus.
- Experience running clinical trial start-up and regulatory submissions.
- Good knowledge of UK systems like IRAS, CPMS, iCT and ARSAC.
- A solid understanding of ICH-GCP, EU CTR, and local regulations.
- Strong communication skills and the ability to lead teams through complex, fast-changing work.
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Senior Clinical Trial Manager in Welwyn employer: Talentmark
Join a leading global manufacturing company that values innovation and collaboration, offering a dynamic work culture where your contributions as an Analytical Chemist will directly impact product quality and safety. With a commitment to employee growth, you will have access to ongoing training and development opportunities, ensuring you thrive in your career while working in a supportive environment. Located in a vibrant area, this role not only provides competitive pay but also the chance to be part of a forward-thinking team dedicated to excellence.
