Senior Clinical Trial Manager

Responsibilities

• Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities
• Provide strategic leadership and operational oversight for global clinical trials from study start-up through closeout
• Serve as the primary operational lead and escalation point for CROs
• Draft, review, and approve study-related plans, processes, and documents including Informed Consent Forms and monitoring plans
• Lead Risk Based Quality Management activities and ensure timely resolution of signals and actions
• Lead sponsor oversight of CRO monitoring activities
• Perform quality oversight visits with a focus on inspection readiness
• Lead and review clinical data listings, reports, and dashboards
• Oversee maintenance, quality, and completeness of the Trial Master File (TMF)
• Manage, mentor, and provide guidance to CTMs, CRAs, and other Clinical Operations team members
• Represent Clinical Operations on cross-functional study teams and governance meetings

Requirements

• Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related areas preferred
• 8-10+ years of clinical operations experience in sponsor pharmaceutical or biotechnology organizations
• 7+ years of direct clinical trial management experience overseeing phase II/III international oncology clinical trials
• Ability to travel internationally to clinical sites and study meetings (up to 20%)
• Proven capability to interpret complex scientific concepts and analyze clinical data
• Expert knowledge of the drug development process, ICH guidelines, and GCP
• Excellent planning, leadership, communication, and organizational skills

About the Company

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs through clinical studies in the field of oncology.