Clinical Trials Manager - Oncology in Uxbridge

Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead's products. You will manage a geographical region(s) of assigned clinical studies or multiple components of larger studies. You will typically manage Phase II-III studies or other oncology studies. You will define and incorporate study logistics and study plans to accomplish clinical study objectives. You may also participate in strategic initiatives.

Responsibilities

• Manage all components of clinical studies, including Phase II-III studies.
• Lead contract research organization (CRO) and vendor selection, and manage interactions and deliverables from relevant CROs and vendors.
• Serve as the key operational contact for Gilead studies, overseeing site evaluation, initiation, close‑out, and routine monitoring visits.
• Define and develop the study logistics and clinical study plan for assigned studies.
• Manage study timelines, documentation, and communications.
• Participate in and manage project meetings and conference calls with CROs, other vendors, and cross‑functional teams.
• Contribute to SOP development and participate in special projects; develop tools and processes to optimize project efficiencies and effectiveness.
• Provide input into study protocols and case report forms, author informed consents, study plans, and presentations.
• Provide oversight of study sites/region and review routine regulatory documents to ensure compliance with protocols, regulatory requirements, SOPs, and monitoring plans.
• Present at internal or external meetings, such as investigator meetings, if required.
• Lead or assist in the preparation of safety, interim and final study reports, including resolving data discrepancies.
• Proactively identify operational challenges and collaborate with other Clinical Operations colleagues to ensure study execution remains on track to defined protocols, budgets, and timelines.
• Assist in training new or less experienced colleagues.
• Ensure own work complies with established practices, policies, processes, and regulatory requirements.

Qualifications and Experience

• BA/BS, MA/MS, PharmD, or PhD, or equivalent with significant relevant clinical or related experience in life sciences.
• Multiple years of clinical or related experience in life sciences, including experience leading or managing less complex studies and project teams.
• Experience managing the work of external vendors.
• Experience specific to running Phase II-III oncology studies within EMEA.
• Experience with regulatory and site start‑up requirements for clinical sites and hands‑on experience filing clinical trial applications in key EMEA countries such as the UK, EU (big 5), and Israel.
• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change and to move between projects easily while providing support and expertise where needed.
• Ability to manage any component of full‑cycle study management, from start‑up to close‑out.
• Advanced knowledge of study management best practices and tools, with a proven ability to apply these to improve study efficiencies and effectiveness.
• Full understanding of protocol requirements, with the ability to articulate and interpret them effectively.
• Knowledge of FDA, EMA, and other applicable national regulations, ICH guidelines, and Good Clinical Practice (GCP) governing the conduct of clinical studies.
• Familiarity with standard medical and scientific terminology.
• Ability to communicate in a clear and concise manner.
• Ability to support a team‑oriented, highly matrixed environment.
• Ability to execute multiple tasks as assigned.
• When needed, ability to travel.