Senior Clinical Trial Manager

Summit Therapeutics Plc • Menlo Park, CA

390d • $165,000 - $195,000

About The Position

The Senior Clinical Trial Manager 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 manager is accountable for performance metrics and the quality of deliverables throughout the clinical trial process.

Requirements

• Bachelor's degree or equivalent in life science, nursing, pharmacy, or medical laboratory technology.
• A minimum of 8+ 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%).
• Proven proficiency in overseeing large complex studies managed in-house and by a CRO.
• Demonstrated ability to lead teams in a fast-paced environment.
• Experience in building relationships with KOLs and site personnel.
• Ability to engage and collaborate with overseas clinical operations teams.
• Demonstrated ability to build and deliver on patient enrollment strategies.
• Excellent interpersonal and decision-making skills.
• Ability to comprehend complex scientific concepts and data.
• Proficient in reviewing and assessing clinical data.
• Excellent planning, time management, and coordination skills.
• Demonstrated problem-solving abilities and clear judgment in regulatory matters.
• Experience in a small organization.
• Excellent written and oral communication skills.
• Proficient in MS Office suite and electronic document management systems.
• Strong computer and database skills.
• Attention to detail, accuracy, and confidentiality.

Nice To Haves

• Experience with electronic document management systems and document review tools.

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 robust ongoing data monitoring strategies are developed and executed effectively.
• Proactively identifies and manages study-related risks.
• Develops and manages clinical trial documents including protocols, CRFs, 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.
• Reviews monitoring visit reports and provides updates to the broader team.
• Directs investigator performance and addresses conduct issues as necessary.
• Oversees maintenance of the TMF and ensures completeness at study end.
• Performs periodic QC of the TMF.
• Ensures compliance with Good Clinical Practices and regulatory requirements.
• Maintains the study in an 'inspection ready' state at all times.
• Coaches Clinical Trial Associates allocated to the project.
• Performs all other duties as assigned.

Benefits

• Competitive salary range of $165,000 to $195,000 annually, based on experience and location.
• Potential for bonuses, stock options, and other variable compensation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree