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)

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical data standardsclinical database developmentMedidata RaveCDISCEDC toolsdata documentationprocess improvementdrug development processHealth Authority regulationsGCP/ICH guidelines

Soft Skills

communicationorganizational skillsindependenceteam collaborationmeeting documentation