Senior Clinical Trial Manager

🕒 September 14

🇺🇸 United States – Remote

💵 $158k - $185k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 5%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

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 for complex global clinical trials. • Lead study deliverables across assigned sites, countries, or regions from protocol development support through 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, data quality, and monitoring strategies. • Draft, review, and approve study plans, processes, and documents, including informed consent forms, investigator agreements, CRFs, analysis plans, monitoring plans, data management plans, and safety monitoring activities. • Review and approve essential document packages and critical study deliverables. • Lead risk-based quality management activities and resolve signals, actions, risks, and trends. • Oversee CRO monitoring activities and review monitoring trip reports. • Perform quality oversight visits focused on inspection readiness. • Lead review of clinical data listings, reports, and dashboards; identify trends and risks and drive cross-functional resolution. • Oversee Trial Master File maintenance, quality, completeness, and reviews. • Ensure clinical trial activities comply with Good Clinical Practices and national and international 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 and contribute to Clinical Operations processes and standards. • Represent Clinical Operations on cross-functional study teams and governance meetings. • Perform other duties as assigned.

🎯 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% depending on project needs. • Ability to interpret complex scientific concepts and critically assess clinical data. • Proficiency overseeing large, complex studies managed in-house and by a CRO. • Ability to problem-solve regarding 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, ICH guidelines, and GCP. • Deep understanding of all phases of clinical trial execution and ability to apply this knowledge to complex global studies.

🏖️ Benefits

• Bonus • Stock • Benefits • Potential variable compensation • International travel opportunities (up to 20%)

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume