Sr Clin Data Mgmt Assoc

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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 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 Description   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.    You will act as the CDM lead on one or more clinical studies. You will lead the preparation of CRF/eCRF design. You will review study protocols and assist in the planning and implementation of CDM portions of clinical studies. You may act as lead in the oversight of vendors to ensure high quality processes for data review, data transfers and reporting. You will use standard / routine and non-routine reports to track study progress and ensure timelines and quality expectations are met. You will provide guidance and training to contract research organizations (CROs), vendors, investigators and study coordinators on CDM requirements.  You will also support regulatory submissions of assigned projects.   RESPONSIBILITIES:    • Serves as lead for one or more studies or projects of increasing complexity, including participating in or leading cross-functional working groups.    • Reviews study protocols and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet protocol requirements in a timely manner.   • Identifies, tracks, and resolves CDM queries and issues.   • Acts as a point of contact for study management teams and for Clinical Development regarding data management issues.   • Works collaboratively with other colleagues to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.     • Ensures completeness, accuracy and consistency of routine clinical data and data structure.   • Ensures adherence to standard business processes within CDM systems to assure compliance with regulatory requirements.    • May lead the design and implementation of the CDM process with vendors, including data entry, data quality checking, data transfer, reporting, backup and recovery.    • Educates study teams and vendors on CDM processes and deliverables, including deviations from established processes.    • Leads the preparation of CRF/eCRF design.      • Utilizes reports to track study progress and ensures timeliness and quality expectations are met.   • Provides technical and business process expertise on new and emerging technologies / vendors for clinical trial execution.    • Leads or otherwise participates in the development, review and

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