Sr Clinical Data Management Manager

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 help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.   Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.   We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Overview Clinical Data Management (CDM) supports drug discovery, development and marketed products across Gilead by ensuring the accurate and timely acquisition, analysis and reporting of diverse clinical data through CRF / eCRF design, editing specifications and query resolution processes. CDM also manages data transfers from vendors, such as central labs and others including eCOA providers and other external technology partners.   You will serve as a Sr. Clinical Data Management Manager with primary responsibility for the oversight and operational management of patient-centric data collection technologies, including eCOA and related digital solutions across the clinical development portfolio. In this role, you will provide leadership and oversight for eCOA vendors, ensuring the successful implementation, quality, compliance, and delivery of patient-reported and other patient-centric clinical trial data.   You will partner closely with Clinical Operations, Biostatistics, Statistical Programming, Technology teams, CROs, and external vendors to support technology implementation and study execution activities, including requirements review, system and study design discussions, user acceptance testing (UAT), issue management, risk identification and mitigation, vendor governance, and operational oversight. You will monitor vendor performance through key metrics and quality indicators, manage escalations, identify process improvement opportunities, and help drive consistency, efficiency, and inspection readiness across studies.   In addition, you will contribute to the evaluation and adoption of innovative technologies, analytics, automation, and digital capabilities that improve operational efficiency, vendor oversight, study execution, and data quality. You may also lead cross-functional initiatives focused on process optimization, standards development, and continuous improvement of patient-centric data collection solutions and associated business processes.

Serves as the CDM subject matter expert for eCOA and other patient-centric data collection technologies across one or more studies, programs, or therapeutic areas. Provides oversight of eCOA vendors and technology partners to ensure successful implementation, quality, compliance, and delivery of patient-reported and other patient-centric clinical trial data. Reviews study protocols and participates in study planning activities to ensure patient-centric data collection requirements are appropriately incorporated into study execution. Leads the review of vendor requirements, specifications, and study documentation to ensure alignment with protocol objectives, business requirements, and operational standards. Lead the evaluation, adoption, and implementation of innovative technologies,