Clinical Trial Manager II

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $122k - $145k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.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

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

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

Upload Resume

Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2003

🏥 Healthcare

💼 Consulting

📣 Marketing

🔥 Funding within the last year

💰 $500M Post-IPO Equity - Summit Therapeutics on 2025-10

Healthcare • Consulting • Marketing

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of novel medicinal therapies to improve quality and duration of life for patients with serious unmet medical needs. The company is advancing ivonescimab (SMT112), a novel bispecific antibody targeting PD-1 and VEGF, through multiple Phase 3 clinical trials for non-small cell lung cancer and other solid tumors under license from Akeso. Summit emphasizes clinical development, regulatory filing strategies, and potential commercialization in its licensed territories while promoting patient- and caregiver-friendly treatment options.

📋 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, including laboratory, imaging, and other protocol-required assessments • 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 creation and execution of clinical trial activities in accordance with Good Clinical Practices and ensure regulatory compliance • Ensure inspection readiness • Mentor and provide guidance to 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 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 proficiency in reviewing and assessing 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 • Problem-solving and sound judgment related to regulatory requirements, external-party interactions, timelines, and moderately to high clinical programs • Strong planning, communication, and organizational skills • Solid understanding of the drug development process, ICH guidelines/GCP, and each step within the clinical trial process

🏖️ Benefits

• Potential bonus • Stock • Benefits • Other applicable variable compensation • Equal Opportunity Employer commitment and diverse work environment