Senior Clinical Trial Manager

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

💵 £71.6k - £85k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 13%

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2003

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of innovative medicinal therapies aimed at improving quality of life for oncology patients. The company is particularly committed to addressing serious unmet medical needs through its lead investigational therapy, ivonescimab, a novel bispecific antibody designed to target both PD-1 and VEGF. Summit’s initiatives include ongoing Phase III clinical trials to evaluate ivonescimab's effectiveness in treating non-small cell lung cancer, highlighting their dedication to patient-centered care and technological advancement in the field of oncology.

📋 Description

• Provide strategic leadership and operational oversight of complex global clinical trials • Lead deliverables at assigned sites, countries, or regions • Support protocol development through study closeout and inspection readiness • Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout • Serve as primary operational lead and escalation point for CROs • Develop and implement patient enrollment, retention, and data quality strategies • Draft, review, and approve study plans, processes, and documents • Review and approve essential document packages and critical study deliverables • Lead Risk Based Quality Management activities and resolve signals and actions • Oversee CRO monitoring activities, review monitoring reports, and address cross-site trends and risks • Perform quality oversight visits focused on inspection readiness • Review clinical data listings, reports, and dashboards; identify trends and risks • Oversee Trial Master File quality and completeness and lead TMF quality reviews • Ensure clinical trial activities comply with Good Clinical Practices and regulatory requirements • Lead audit and regulatory inspection preparation and support inspection management • Manage, mentor, and guide CTMs, CRAs, and other Clinical Operations personnel • Drive continuous improvement initiatives and develop Clinical Operations processes and standards • 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 visit clinical sites and study meetings, up to 20% • Proficiency in reviewing, analyzing, and critically assessing clinical data • Proficiency in overseeing large complex studies managed in-house and by a CRO • Ability to problem-solve in relation to regulatory requirements, external parties, timelines, and complex clinical programs • 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 and ICH guidelines/GCP • Deep understanding of all phases of clinical trial execution and ability to apply this knowledge to complex, global studies

🏖️ Benefits

• Potential bonus • Stock • Benefits and/or other applicable variable compensation • International travel opportunities, up to 20% as required by project needs

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