Senior Associate, Clinical Data Standards Management (CDSM)

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. 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 Kite and help create more tomorrows.

The Senior Associate, Clinical Data Standards Management (CDSM) supports the development, implementation, and maintenance of global clinical data standards across clinical programs. This role collaborates with Data Management, Clinical Programming, Biostatistics, and Clinical Operations to ensure consistent, high-quality, and regulatory-compliant standards implementation. The position is a hands-on contributor focused on global library development, governance support, and study-level integration. The Senior Associate, Clinical Data Standards Management reports to the Director of Clinical Data Management (CDSM) and works under the guidance of the Manager, Senior Manager and Associate Director to execute clinical data standards activities. Responsibilities include, but are not limited to:   Support development and maintenance of global clinical data standards and operational data mappings  Apply CDISC standards (CDASH, SDTM controlled terminology) in standards development  Develop and maintain global library objects (eCRFs, edit checks, dynamics etc.)  Assist in regular releases of the Global Library Volume (GLV)   Contribute to CRF Completion Guidelines development  Work within multiple technologies to promote the development, maintenance and releases of the GLV (Medidata RAVE, TrialGrid, Azure, Smartsheet, SharePoint,  Veeva Vault, etc.)  Support consistency and adherence to Kite standards across programs and portfolios  Support Standards Core Committee (SCC) and Standards Governance Committee (SGC) activities including preparation of materials, documentation of decisions and follow-up of action items  Partner with functional stakeholders to support standards adoption  Identify and suggest process improvements and support standards-related initiatives  Ensure compliance with regulatory requirements, industry standards, GCP/ICH guidelines and internal procedures  Provide study support during the initial EDC build on new studies including implementation of standards and facilitating Change Management, issue resolution, impact analysis, proposing solutions and escalation where appropriate.  Execute assigned global library build and maintenance activities  Perform quality checks to ensure standards implementation aligns with defined specifications   Document all standards release activities appropriately  Basic Requirements    Doctorate and Clinical Data Standards or EDC Programming experience OR  Master’s and 3+ years of Clinical Data Standards or EDC Programming experience OR  Bachelor’s and 5+ years of Clinical Data Standards or EDC Programming experience   Preferred Qualifications    Strong desire and passion to work in Clinical Data Standards development with demonstrated interest in process improvement and operational excellence  Working knowledge of CDISC standards (CDASH, SDTM, ADaM)  Experience programming in Medidata Rave EDC   Experience with at least some Medidata Rave modules including Rave Coder, Targeted SDV (TSDV), ePRO, Lab Admin, Rave Safety Gateway (RSG), Core Configuration and IRT Integrations  Experience in global library