Clinical Trial Manager

$135,000 - $155,000/Yr

Summit Therapeutics Sub, Inc. - Menlo Park, CA

Full-time - Senior

Menlo Park, CA

About the position

The Clinical Trial Manager at Summit Therapeutics is a highly autonomous and experienced professional responsible for managing all aspects of clinical trial operations for global studies. This role involves overseeing study start-up, maintenance, and close-out, while coordinating with cross-functional team members, CROs, and vendors to ensure successful delivery of clinical studies. The Clinical Trial Manager is accountable for performance metrics and the quality of deliverables throughout the clinical trial process.

Responsibilities

• Oversees study scope, quality, timelines, and budget with internal functional leads, CRO, and vendors.
• Initiates and builds professional relationships with key opinion leaders and clinical site staff.
• Partners with the CRO to develop and implement patient enrollment strategies.
• Ensures ongoing data monitoring strategies are effective for high-quality data delivery.
• Identifies and manages study-related risks proactively.
• Develops and manages clinical trial documents including protocols and consent documents.
• Reviews and manages study-related plans and processes, including Investigator agreements and monitoring plans.
• Reviews CRO and vendor contracts to meet study objectives.
• Approves essential document packages for timely site activations.
• Provides oversight on monitoring reports and updates the broader team.
• Directs investigator performance and addresses conduct issues as necessary.
• Maintains the Trial Master File (TMF) and ensures completeness at study end.
• Performs periodic quality control of the TMF.
• Oversees clinical trial activities in compliance with Good Clinical Practices.
• Ensures compliance with national and international regulatory requirements.
• Coaches Clinical Trial Associates allocated to the project.

Requirements

• Bachelor's degree or equivalent in life science, nursing, pharmacy, or medical laboratory technology.
• Minimum of 5+ years of clinical project management experience in international clinical trials.
• Prior phase II and III clinical trial experience required.
• Solid understanding of the drug development process and ICH guidelines/GCP.
• Experience with budget forecasting and management.
• Experience with clinical studies in oncology.
• Ability to travel internationally (up to 20%) to visit clinical sites and for study meetings.
• Proven proficiency in overseeing large complex studies managed in-house and by a CRO.
• Demonstrated ability to lead teams in a fast-paced environment.
• Excellent interpersonal and decision-making skills.

Nice-to-haves

• Experience in working in a small organization.
• Demonstrated ability to build and deliver on patient enrollment strategies.
• Proficient in reviewing and assessing clinical data.

Benefits

• Employee stock purchase plan
• Health insurance
• Flexible spending account
• 401(k) with 6% match