Clinical Trial Manager / Sr. Manager

Role: Clinical Trial Manager/Senior Manager responsible for overseeing global clinical trial operations from start-up through close-out, ensuring milestones, quality, and compliance are met. Responsibilities include managing trial activities, developing study protocols and materials, overseeing CRO/vendor performance, risk mitigation, site selection, enrollment, and regulatory compliance; supporting TMF quality and SOP development; collaborating with cross-functional teams such as Biometrics, Quality, Regulatory, and CMC. Requirements: Bachelor's degree plus 8+ years in Clinical Operations, Clinical Development, or Project Management; experienced in managing oncology early-phase trials, especially solid tumors; proficient in global trial oversight, vendor management, and regulatory inspections; strong knowledge of ICH/GCP, EDC, IRT, CTMS, eTMF systems; excellent problem-solving, communication, and collaboration skills. Preferred: biotech/startup experience; RN or CRC background advantageous. High-Value: Oncology, early-phase, solid tumor indications, global trial management, vendor oversight, GCP compliance. Work Setup: Hybrid in South San Francisco, CA, with preference for onsite presence on Mondays and Tuesdays.