Senior Clinical Trial Manager

The role

The Senior Clinical Trial Manager provides strategic leadership and operational oversight for complex global clinical trials. This person is accountable for all aspects of study execution from protocol development through study closeout and inspection readiness.

What you will do

• Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities.
• Serve as the primary operational lead and escalation point for CROs.
• Draft, review and approve study-related plans, processes, and documents.
• Review and approve essential document packages and critical study deliverables.
• 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).
• Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices.

Required qualifications

• 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 visit clinical sites and study meetings (up to 20%).
• Proven capabilities to interpret complex scientific concepts with proficiency in reviewing analyzing and critically assessing clinical data.
• Proven proficiency in overseeing large complex studies being managed in house and by a CRO.
• Demonstrated ability to problem-solve in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
• Demonstrated ability to lead teams and work in a fast-paced team environment.
• Excellent planning, leadership, communication, negotiation, and organizational skills.
• Expert knowledge of the drug development process, ICH guidelines/GCP.

Nice to have

• Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related areas

Benefits

• bonus
• stock
• benefits

About the company

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.