Location
Central London, Gilead European offices

Hours
Full Time

Salary
Negotiable

About the Role
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that improve lives and ensure access globally. Our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in discovering and developing life-changing scientific innovations. As a Clinical Trials Manager (CTM) within Clinical Operations, you will manage a geographical region(s) or multiple components of Post-Authorization Non-Interventional Studies (NIS) to fulfil regulatory commitments, safety obligations, and evidence needs for regulatory filings. You will define and incorporate study logistics and plans to accomplish clinical study objectives and may participate in strategic initiatives or projects. Clinical Operations is responsible for the worldwide execution of all Phase I-IV clinical trials across all Gilead therapeutic areas, ensuring compliance with SOPs, company policies and regulatory guidelines to provide timely, high-quality clinical data supporting global registration and commercialization.

Key Responsibilities
Manage assigned clinical studies or components of larger studies within a geographical region. Collaborate cross-functionally to achieve study goals and communicate effectively with project teams. Oversee and/or manage interactions and deliverables from CROs, subcontractors, and vendors. Serve as the key operational contact for Gilead studies, providing oversight for site evaluation, initiation, close-out visits, and CRO monitoring visits. Define study logistics and develop clinical study plans. Manage study timelines, documentation, and communications. Provide input into study protocols, case report forms, and informed consents. Oversee study sites/region and review regulatory documents to ensure compliance. Lead or assist in preparation of safety, interim, and final study reports, resolving data discrepancies. Identify operational challenges and collaborate on solutions to keep studies on track. Participate or act as Business Lead in initiatives/projects and manage meetings with CROs, vendors, and cross-functional teams. Contribute to SOP development and special projects. Develop tools and processes to optimize project efficiency. Assist in training new or less experienced colleagues. Ensure compliance with established practices, policies, processes, and regulatory requirements.

Experience
MA / MS / PharmD / PhD with 3+ years relevant clinical experience in life sciences, or BA / BS / RN with 5+ years relevant clinical experience. Minimum 2 years Post-Authorization Non-Interventional study management experience at international level. Experience managing site activities as study coordinator or overseeing site activities as Clinical Research Associate (CRA). Experience working with cross-functional stakeholders such as Medical Affairs and Real World Evidence/Epidemiology teams.

About you
Demonstrated ability to learn quickly and adapt to change. Flexible and able to move between projects, providing support and expertise as needed. Strong communication skills with ability to clearly articulate and interpret protocol requirements. Team-oriented and able to work effectively in a highly matrixed environment. Able to manage multiple tasks and priorities. Willingness to travel when required.

Qualifications
Advanced knowledge of study management best practices and tools with proven ability to improve study efficiencies. Thorough understanding of protocol requirements. Knowledge of FDA, EMA, and other applicable national regulations, ICH guidelines, and Good Clinical Practice (GCP). In-depth knowledge of Good Pharmacovigilance Practice (GVP), related key modules, and FDA Real World Evidence guidances. Familiarity with standard medical and scientific terminology. Commitment to compliance with regulatory and company standards.