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Senior Clinical Trial Manager

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Position Summary

Provide end-to-end operational oversight and execution for one or more assigned clinical trials of moderate to high complexity, typically Phase 1-3, from study planning through close-out and Clinical Study Report. This role is accountable for Clinical Operations deliverables, including timelines, budget, quality, risk management, vendor oversight, and inspection readiness, in close collaboration with cross-functional teams, Clinical Research Organizations, and external vendors.

This position serves as the Study Lead for one or more clinical studies, depending on size and complexity, with direct responsibility for day‑to‑day study execution. The role works closely with a cross‑functional team primarily based in the San Francisco Bay Area. Periodic travel to the Burlingame, CA office is required.

Key Responsibilities

• Serve as primary operational lead and point of contact for assigned clinical studies.
• Lead end-to-end execution of assigned clinical trials, including study start-up, conduct, close-out, Clinical Study Report support, and inspection readiness.
• Develop, execute, and maintain integrated study plans, timelines, critical path activities, milestones, and operational plans.
• Proactively identify, assess, and mitigate operational risks and issues throughout the study lifecycle, escalating concerns with clear mitigation strategies as appropriate.
• Ensure study deliverables are completed on time, within budget, and in compliance with applicable regulations, SOPs, and study requirements.
• Lead cross-functional study teams at the study level, coordinating Clinical Development, Data Management, Biostatistics, Medical Writing, Safety, Regulatory Affairs, CMC, and other functional partners.
• Serve as the primary operational point of contact for CROs and key vendors.
• Oversee CRO and vendor performance, including KPIs, issue resolution, deliverable execution, and escalation of concerns as appropriate.
• Participate in vendor selection and governance activities for assigned studies.
• Contribute to forecasting and tracking of clinical trial budgets and expenses.
• Review and approve vendor invoices in alignment with contractual terms and approved budgets.
• Provide Clinical Operations input into protocols, protocol amendments, investigator brochures and Clinical Study Reports.
• Present study status, risks, and mitigation strategies to internal governance forums and senior stakeholders.
• Ensure study-level inspection readiness, including Trial Master File quality, audit support, regulatory inspections, and health authority interactions related to assigned studies.
• Contribute to operational process improvement initiatives and SOP development.
• Provide functional guidance and day‑to‑day support to Clinical Operations team members, as applicable.

Qualifications, Skills, and Experience

• Bachelor’s degree in life sciences or a related field required
• Approximately 6-8 years of experience in clinical operations or clinical trial project management, including hands‑on study execution.
• 4–5 years of sponsor‑side experience at a biotech or pharmaceutical company.
• Recent oncology experience with direct responsibility for study execution and vendor oversight.
• Demonstrated experience leading Phase 1-3 clinical trials with increasing complexity and autonomy.
• Strong experience managing CROs and external vendors at the study level.
• Strong working knowledge of ICH, GCP, and applicable global regulatory requirements.
• Proven ability to lead cross-functional teams through influence rather than authority.
• Strong problem-solving, organizational, and communication skills.
• Ability to manage competing priorities and operate effectively in a fast-paced environment.

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