Clinical Trials Manager

Role: Manage clinical operations for Phase I studies and smaller clinical trials within Gilead's therapeutic areas, ensuring adherence to SOPs, regulatory guidelines, and quality standards. Primary objectives include study execution, site management, vendor oversight, budget control, and cross-functional collaboration to achieve study milestones. Responsibilities encompass overseeing study logistics, timeline management, CRO/vendor interactions, regulatory compliance, and contributing to study documentation such as protocols and reports. Requirements: MA/MS/PhD/PharmD with 3+ years or BA/BS/RN with 5+ years relevant experience in clinical or life sciences, including study management and vendor oversight. Preferred skills include knowledge of GxP, FDA/EMA regulations, ICH guidelines, and experience with clinical trial lifecycle from start-up to close-out. High-value specifics: Involvement predominantly in early-phase (Phase I) clinical trials, with emphasis on biologics or small molecules, across multiple therapeutic areas. Ability to travel as needed. Collaboration involves cross-functional teams, CROs, and vendors to support clinical study success. Work setup: Full-time, with some travel required.