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-line management responsibilities.
- Travel up to 10% as required to support study oversight and site engagement
QUALIFICATIONS
- Bachelor's degree in life sciences or related field with 7+ years of progressive clinical trial management experience in biotech, pharmaceutical, and/or CRO environments
- Demonstrated expertise managing clinical trials from start-up through close-out, with experience overseeing global, multi-site studies and CRO partners
- Experience in oncology clinical trials required; solid tumor and early-phase (Phase I/Ib or II) experience preferred
- In-depth knowledge of ICH-GCP, FDA/EMA regulations, and global regulatory requirements, with a strong focus on quality and inspection readiness
- Proficiency with clinical trial systems, including CTMS, eTMF platforms, IRT systems, EDC systems, and safety databases
- Ability to thrive in a collaborative, fast-paced, growth-stage biotech environment with evolving priorities and high accountability
PAY AND BENEFITS
We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.
