Senior Clinical Trial Manager

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