Role Description
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. This role drives high-quality, inspection-ready trial execution within a collaborative, growth-stage biotech environment.
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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.
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Lead cross-functional study teams and drive alignment across Clinical Development, Regulatory, Biometrics, and external partners.
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Develop and execute enrollment, site management, and monitoring strategies to ensure high-quality trial conduct and performance.
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Oversee CRO and vendor performance, including KPI management, monitoring quality oversight, document review and approval, and vendor selection support.
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Partner with Data Management and Medical to conduct ongoing data review and ensure timely query resolution.
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Develop and manage key study documents and operational tools, including protocols, informed consent forms, project plans, budgets, and study materials.
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Lead study-related training for investigators, site personnel, and internal teams.
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Proactively identify, assess, and escalate operational risks with mitigation strategies and clear recommendations.
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Mentor and support junior clinical operations staff, including potential dotted-line management responsibilities.
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Travel up to 10% as required to support study oversight and site engagement.
Qualifications
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Bachelorβs degree in life sciences or related field with 7+ years of progressive clinical trial management experience in biotech, pharmaceutical, and/or CRO environments.
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Demonstrated expertise managing clinical trials from start-up through close-out, with experience overseeing global, multi-site studies and CRO partners.
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Experience in oncology clinical trials required; solid tumor and early-phase (Phase I/Ib or II) experience preferred.
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In-depth knowledge of ICH-GCP, FDA/EMA regulations, and global regulatory requirements, with a strong focus on quality and inspection readiness.
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Proficiency with clinical trial systems, including CTMS, eTMF platforms, IRT systems, EDC systems, and safety databases.
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Ability to thrive in a collaborative, fast-paced, growth-stage biotech environment with evolving priorities and high accountability.
Benefits
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Industry leading competitive pay.
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Company paid healthcare.
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Flexible spending accounts.
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Voluntary life insurance.
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401K matching.
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Uncapped vacation.
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State-of-the-art facility in beautiful San Diego with an onsite gym and dining.
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Easy access to great places to live and play.