Senior Clinical Trial Manager, Clinical Operations

JOB SUMMARY

The Senior Clinical Trial Manager, Clinical Operations, serves as the operational lead for assigned early-phase oncology studies, providing end-to-end trial leadership from start-up through close-out. In close partnership with Clinical Development, Regulatory, Biometrics, and external CROs, this role drives high-quality, inspection-ready trial execution within a collaborative, growth-stage biotech environment. The Senior CTM is accountable for vendor oversight, risk management, timeline and budget performance, and cross-functional alignment to ensure studies are delivered efficiently and in compliance with global regulatory requirements, ICH-GCP, and company SOPs. This position reports to the Director of Clinical Operations and can be remote or onsite in San Diego.

KEY RESPONSIBILITIES

- Provide end-to-end operational leadership for complex clinical trials from start-up through close-out, ensuring delivery on time, within budget, and in compliance with global regulations and company SOPs

- Lead cross-functional study teams and drive alignment across Clinical Development, Regulatory, Biometrics, and external partners

- Develop and execute enrollment, site management, and monitoring strategies to ensure high-quality trial conduct and performance

- Oversee CRO and vendor performance, including KPI management, monitoring quality oversight, document review and approval, and vendor selection support

- Partner with Data Management and Medical to conduct ongoing data review and ensure timely query resolution

- Develop and manage key study documents and operational tools, including protocols, informed consent forms, project plans, budgets, and study materials.

- Lead study-related training for investigators, site personnel, and internal teams.

- Proactively identify, assess, and escalate operational risks with mitigation strategies and clear recommendations.

- Mentor and support junior clinical operations staff, including potential dotted...