Clinical Trial Manager II

🔥 1 hour ago

🌐 United Kingdom, Ireland – Remote

🇬🇧 United Kingdom – Remote 🇮🇪 Ireland – Remote

💵 $67k - $79k / year

⏰ Full Time

🟡 Mid-level

🟠 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

• Oversee site selection, feasibility, activation, enrollment, monitoring, issue escalation, and closeout activities • Partner with the CRO to ensure robust clinical trial execution, data monitoring strategies, and patient enrollment strategies • Draft, review, and manage study-related plans and processes, including informed consent forms, investigator agreements, CRFs, CRF guidelines, statistical/pharmacokinetic analysis plans, monitoring plans, data management, and safety monitoring as delegated • Review and approve essential document packages • Track and ensure resolution of Risk Based Quality Management actions and signals • Conduct sponsor oversight of CRO monitoring activities by reviewing monitoring reports, monitoring site performance, identifying quality trends, and resolving findings and action items • Perform quality oversight visits • Review clinical data listings, reports, and dashboards for currency and completeness • Identify trends and follow up on outstanding data issues with the CRO and study team • Oversee maintenance and completeness of the TMF and perform periodic quality reviews • Oversee clinical trial activities in accordance with Good Clinical Practices and ensure regulatory compliance • Ensure inspection readiness • Mentor and guide CTMs, CRAs, and other Clinical Operations team members • Perform other assigned duties

🎯 Requirements

• Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred • 6+ years of clinical trial management experience in conducting international clinical trials in sponsor Pharma/Biotech organization • 5+ years of direct clinical trial management experience including oversight of Phase II/III clinical trials • Ability to travel internationally to visit clinical sites and study meetings, up to 20% • Ability to comprehend complex scientific concepts and review and assess clinical data • Planning, time management, and project coordination skills • Ability to identify and manage operational risks and develop effective mitigation strategies • Ability to work independently and collaboratively in a fast-paced environment • Ability to solve problems and use sound judgment in relation to regulatory requirements, external parties, timelines, and moderately to highly complex clinical programs • Strong planning, communication, and organizational skills • Understanding of the drug development process, ICH guidelines/GCP, and each step of the clinical trial process

🏖️ Benefits

• Bonus, stock, benefits and/or other applicable variable compensation may be included in the total compensation package • International travel opportunities, up to 20% depending on project needs

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