Clinical Trial Manager

Overview of Role The Clinical Trial Manager is a highly autonomous and experienced clinical operations professional responsible for all aspects of clinical trial management for global studies, from study start‑up through close‑out, ensuring study scope, quality, timelines, and budget and coordinating cross‑functional teams, CROs, and vendors. Role and Responsibilities Oversees study scope, quality, timelines, and budget with Summit functional leads, CROs, and vendors to ensure overall project objectives are met. Initiates and builds solid professional relationships with key opinion leaders and clinical site staff. Partners with the CRO to develop and execute robust patient enrollment strategies to complete enrollment on time. Ensures robust ongoing data monitoring strategies are implemented to deliver high‑quality data. Proactively identifies and manages study‑related risks. Develops and manages clinical trial documents including protocols, case report forms (CRFs), consent documents, and confidentiality agreements. Reviews and manages study‑related plans and processes: investigator agreements, CRFs, CRF guidelines, statistical/pharmacokinetic analysis plans, monitoring plans, data management, and safety monitoring. Reviews CRO and vendor contracts/work orders and specifications to enable study objectives to be met. Approves essential document packages to enable timely site activations. Reviews pre‑study, study initiation, interim monitoring visit, and close‑out visit reports. Analyzes monitoring reports and loops back with the broader team to provide updates. Directs investigator performance and adherence to protocol and addresses conduct issues and enrollment problems as necessary. Oversees maintenance of the Trial Master File (TMF) and ensures completeness at study end. Performs periodic quality control of the TMF. Oversees creation and execution of clinical trial activities in accordance with Good Clinical Practices, ensuring compliance with national and international regulatory requirements. Ensures the study is always inspection‑ready. Oversees and coaches the Clinical Trial Associates allocated to the project. Performs any other duties as assigned. Experience, Education, and Skills Bachelor’s degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology, or a related health/medical field. 5+ years of clinical project management experience conducting international Phase II/III trials in a sponsor Pharma/Biotech organization. Solid understanding of the drug development process, ICH GCP guidelines, and all steps of the clinical trial process. Experience with budget forecasting and management. Experience with oncology clinical studies. Ability to travel internationally for site visits and study meetings (up to 20%). Proven proficiency overseeing large complex studies in house and by a CRO. Demonstrated ability to lead teams and work in a fast‑paced environment. Experience building relationships with KOLs and site personnel. Ability to engage collaboratively with overseas clinical operations team members. Proven ability to design and deliver patient enrollment strategies. Excellent interpersonal and decision‑making skills, with innovation and enthusiasm to achieve program objectives. Ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data. Excellent planning, time‑management, and coordination skills. Strong problem‑solving and judgment in regulatory and operational contexts. Experience working in a small organization. Excellent written and oral communication skills. Pay Transparency $140,000 - $150,000 USD Actual compensation packages are based on factors such as skill set, depth of experience, certifications, and location. The total package may include bonus, stock, benefits, and other variable compensation. Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. #J-18808-Ljbffr