Therapeutic Area Manager focusing on NeuroImmunology at Genentech. Engaging with healthcare practitioners to improve patient outcomes and represent products ethically.
GS
Hybrid Manager, Clinical Programming – Clinical Data Standards Management
Posted last month
About the role
- Manager, Clinical Programming responsible for developing and maintaining global clinical data standards. Join Kite in their mission to cure cancer by enabling innovative cancer therapies.
Responsibilities
- Participate in the development and maintenance of global clinical data standards
- Manage work assignments to ensure timely delivery of global library objects
- Support and participate in the Standards Core Committee (SCC)
- Document meeting minutes and other discussions
- Build, maintain, and document the Medidata Rave global library standard objects
- Communicate and reinforce content and interpretation of Kite data standards to project and study teams
- Independently identify and propose process improvements
Requirements
- PhD in life sciences or related discipline and 0+ years of experience OR MS/MA in life sciences or related discipline and 4+ years of experience in Clinical Data Standards OR BS/BA in life science or related discipline and 6+ years of experience in Clinical Data Standards OR High School degree and 10+ years of experience in Clinical Data Standards
- 6+ years of relevant industry experience with clinical trials
- Experience in Industry Standards (e.g., CDISC)
- At least 8 years of clinical database developer experience in Rave
- Strong understanding of the drug development process
- Strong knowledge of industry-leading EDC tools (e.g., Medidata Rave, Veeva, Medrio, Oracle, TrialGrid)
- Experience interpreting Health Authority regulations and GCP/ICH guidelines
Benefits
- company-sponsored medical, dental, vision, and life insurance plans*
- paid time off
- discretionary annual bonus
- discretionary stock-based long-term incentives (eligibility may vary based on role)
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