Senior Associate, Clinical Data Standards Management (CDSM)
Gilead Sciences · Remote
BiometricsRemoteFull-time$124k–$160kCompany career page
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Role summary
Senior Associate role supporting development and implementation of clinical data standards across Kite's global cancer therapy programs. Collaborates with data management, programming, and biostatistics teams to ensure regulatory-compliant standards and maintains global library objects for electronic data capture systems.
What they're looking for
- Doctorate degree plus clinical data standards or EDC programming experience
- OR Master's degree plus 3+ years clinical data standards or EDC programming experience
- OR Bachelor's degree plus 5+ years clinical data standards or EDC programming experience
- Working knowledge of CDISC standards (CDASH, SDTM, ADaM)
- Experience with Medidata Rave EDC platform and modules
- Strong communication and cross-functional collaboration skills
- Detail-oriented with ability to ensure consistency across clinical studies
What you'll be doing
- Support development and maintenance of global clinical data standards and operational data mappings
- Develop and maintain global library objects including eCRFs, edit checks, and dynamics
- Apply CDISC standards in standards development and assist with Global Library Volume releases
- Support Standards Core Committee and Standards Governance Committee activities including documentation and decision tracking
- Provide study support during EDC build including standards implementation, change management, and issue resolution
Privacy & handoff
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