Clinical Operations Lead
3 days ago
At Adaptimmune, we are seeking a highly experienced Clinical Operations Lead to join our team in the UK. This is a global role that requires strong leadership and management skills, as well as extensive experience in clinical trial management.
About the RoleThis is a key position within our Clinical Development Operations function, responsible for leading cross-functional teams in the planning, execution, and delivery of clinical trials. The successful candidate will have a deep understanding of clinical operations, regulatory requirements, and the ability to develop and implement effective strategies to drive project success.
Key Responsibilities- Lead global clinical trial delivery, including study planning, management, and reporting, in accordance with company plans and objectives.
- Develop and maintain effective relationships with clinical sites and Key Opinion Leaders (KOLs) globally.
- Provide guidance on protocol development and procedures in the development of eCRF design.
- Review and monitor data quality, ensuring appropriate quality measures are in place to identify any issues with data metrics and integrity.
- Support and review of study and site budgets, including vendor contracts, POs, and invoice approval.
- Minimum BA/BS in Life Sciences Degree.
- Extensive industry-sponsored clinical trial management experience required, including experience with biologics or cell and gene therapy in FIH, POC, and phase I/II studies.
- Strong knowledge of clinical operations and the regulatory process, including experience in independently leading multiple clinical trials within the oncology therapeutic area.
- EDC experience, including trial management, data review, queries, CRF design/review/approval.
- Experience writing scientific documents and managing direct reports.
We offer a competitive salary of £90,000 - £120,000 per annum, depending on experience, plus a range of benefits, including health insurance, pension scheme, and professional development opportunities.
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