We are seeking an experienced Clinical Trial Manager to join a London-based biotech and lead the planning, execution, and delivery of clinical trials. The successful candidate will excel in fast-paced, dynamic biotech settings and be committed to driving trials that meet the highest standards of quality, compliance, and operational excellence.
Responsibilities:
* Lead the design, start-up, and execution of clinical trials, ensuring projects are completed on schedule, within scope, and aligned with budgetary expectations.
* Serve as the primary sponsor contact for CROs, investigators, and providers.
* Oversee CRO performance, including reviewing monitoring outputs and KPIs.
* Work closely with Regulatory Affairs on ethics/regulatory submissions, ensuring alignment with ICH-GCP guidelines and current UK/EU regulations.
* Maintain trial inspection readiness, overseeing safety reporting, audit response, and vendor governance.
* Develop and review protocols, informed consent forms, and study reports.
* Drive risk management, issue resolution, and collaboration across cross-functional teams.
* Play an active role in refining operational processes and SOPs within the Clinical Operations function.
Requirements:
* Bachelor's degree (or equivalent) in a life science or health-related discipline.
* Minimum of 8 years in clinical trial management across pharma, biotech, or CROs.
* Site monitoring experience or proven ability to critically evaluate CRO monitoring performance.
* In-depth understanding of ICH-GCP and global regulatory requirements, with strong understanding of upcoming UK/EU regulatory changes (e.g., UK CTR 2026).
* Demonstrated success in managing CROs and vendors, including financial oversight.
* Skilled at balancing multiple priorities and tight timelines.
* Proficient in navigating lean, fast-paced environments; direct experience in biotech settings is valued.
* Strong interpersonal and communication skills, with proven ability to manage internal stakeholders with accountability and transparency.
* Able to work on-site in central London in a hybrid capacity.