About this role
Lead the Global Clinical Data Standards program, defining standard data definitions, ensuring CDISC alignment, and guiding data governance and lifecycle activities across clinical programs.
Key Responsibilities
- Define standard data definitions
- Maintain alignment across lifecycle
- Lead data governance reviews
- Contribute to business processes
- Mentor cross-functional teams
Technical Overview
Focus on CDISC standards, SDTM, InForm, and ED C systems; responsible for data definitions, governance, and reporting, with collaboration across cross-functional teams.
Ideal Candidate
The ideal candidate is an experienced clinical data management professional with 6+ years in data standards development (or 8+ years in data management), strong SDTM and InForm expertise, and a track record leading data governance initiatives in a CDISC-compliant environment.
Must-Have Skills
Bachelor's degree8+ years' experience including 4 years data management and 2 years in clinical data standards development; or 6+ years with advanced degree and 2 years in clinical data standards developmentAdvanced knowledge of clinical data standardsSDTM expertiseInForm expertiseAnalysis & Reporting experienceProgram-level clinical and business requirements knowledgeStrong communication and presentation skillsProficient in educationtrainingand facilitationInnovative spirit and leadership with multiple projects managementKnowledge of clinical data management
Nice-to-Have Skills
Lead standards data governance reviewsCross-functional collaboration
Required Skills
Bachelor's degree; SDTM; InForm; CDISC; EDC; Data Governance; Data Standards; Data Management; GCDMP; GCP; SDTM expertise; SDTM; Analysis & Reporting
Hard Skills
CDISCCDISC standardsSDTMStudy Data Tabulation ModelInFormInForm expertiseElectronic Data Capture (EDC)Electronic Data CaptureData GovernanceData ManagementGCDMPGCPAnalysis & Reporting
Soft Skills
LeadershipCommunicationPresentationInterpersonal RelationshipsMentoring StaffProblem SolvingDetail-Oriented
Keywords for Your Resume
associate directorclinical data managementCDISCCDISC standardsSDTMStudy Data Tabulation ModelInFormElectronic Data Capture (EDC)EDCData governanceData standardsClinical Data Standards DevelopmentGCDMPGCPAnalysis & Reportingprogram-level clinical and business requirementscommunicationpresentationleadershipmulti-project managementcdisc standardssdtminformatedcdata governancedata standardsproject management
Deal Breakers
Lack of SDTM or InForm experience, Less than 6 years with advanced degree or 8+ years without advanced degree, No experience with CDISC standards or data governance
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