We have an exciting opportunity for motivated individuals to join our clinical operations team working to bring cell therapies to the clinical stage.
Position Title: Senior Clinical Trial Manager
Location: Alameda, CA (hybrid schedule)
Reports to: Senior Clinical Operations Director
Ideal candidate will have the following education & experience:
- Bachelor's degree or higher in healthcare or life sciences
- 6+ years in Clinical Research, including 3+ years as Senior/Principal CRA or 2+ years in a Clinical Trial Manager role
- Knowledge of ICH/GCP guidelines and oncology experience preferred
Responsibilities include, but are not limited to:
- Lead and manage clinical trials, including planning, budget oversight, and metrics tracking
- Ensure trials comply with protocol, regulatory requirements, and quality assurance measures (including CAPA documentation and resolution); ensures audit-ready condition of clinical trial documentation with vendors and CROs.
- Handle study submissions to regulatory bodies and IRBs, and lead vendor selection and management
- Oversee study budgets, review invoices, and manage revisions with vendors
- Coordinate site selection, startup processes, and maintain relationships with investigators and staff
- Collaborate cross-functionally to optimize trial operations
- May require occasional domestic and/ or international business travel.
- May require occasional evening working hours for attending international teleconferences
