Clinical Data Management Manager

Role: Lead Clinical Data Management (CDM) activities for Gilead's drug development programs, overseeing data collection, quality, and reporting across complex studies. Responsibilities: design CRF/eCRF, review protocols, coordinate vendor activities, resolve data queries, ensure regulatory compliance, and support audits. Lead CDM project planning, monitor progress, and facilitate communication with study teams, CROs, and regulatory bodies. Qualifications: Bachelor's degree with 6+ years or Master's with 4+ years in clinical data management or related fields; proficiency with FDA/EMA regulations, EDC systems, and data analytics tools. Preferred: experience leading small projects, strong understanding of regulatory requirements, risk management, and cross-functional collaboration skills. HighValue: expertise in biologics or viral therapies, clinical phases I-III, data transfer/vendor oversight, GxP compliance, and supporting regulatory submissions. WorkSetup: not explicitly specified; travel when needed.