About this role
Associate Director, Clinical Data Management at Merck leads standard data definitions and governance for clinical data standards across lifecycle, aligning with CDISC and Health Authority regulations. The role requires SDTM and InForm expertise and cross-functional leadership to drive data standardization and process improvements in a hybrid work environment.
Technical Overview
Focus on CDISC data standards (SDTM), InForm EDC, data governance, and regulatory compliance. Senior-level program management with cross-functional collaboration in a pharmaceutical environment.
Ideal Candidate
The ideal candidate is an experienced clinical data management professional with 6+ years of data management and SDTM/CDISC standards development experience, strong leadership, and ability to drive data standardization across lifecycle.
Must-Have Skills
B.A. or B.S. degree8+ years data management experienceSDTM expertiseStudy Data Tabulation Model (SDTM) expertiseInForm expertiseElectronic Data Capture (EDC)Data governanceData collection methodsData analysisStrong communication and presentation skillsProgram-level clinical and business requirements knowledge
Tools & Platforms
InFormElectronic Data Capture (EDC) systems
Required Skills
BA/BS degreedata managementdata standardsSDTMStudy Data Tabulation ModelCDISCInFormElectronic Data Capture (EDC)EDCGood Clinical Data Management Practice (GCDMP)Good Clinical Practice (GCP)GCPdata governancedata collection methodsdata analysisregulatory requirementsHealth Authority regulationsleadershipproject managementtrainingfacilitation
Hard Skills
SDTMStudy Data Tabulation ModelInFormElectronic Data Capture (EDC)EDCCDISCData GovernanceData Quality AssuranceData Collection MethodsData AnalysisGCDMPGCPGood Clinical PracticeRegulatory requirementsHealth Authority regulationsLeadershipProject ManagementClinical Data Standards
Soft Skills
Strong communication skillsLeadershipPresentation skillsInterpersonal skillsCollaborationProblem-solvingDetail-oriented
Keywords for Your Resume
Associate DirectorClinical Data ManagementHybridSDTMStudy Data Tabulation ModelCDISCInFormElectronic Data CaptureEDCData GovernanceData Quality AssuranceData Collection MethodsData AnalysisGCDMPGCPGood Clinical PracticeRegulatory requirementsHealth Authority regulationsLeadershipProject ManagementTrainingFacilitation8+ years data management3+ years SDTMclinical data standards development
Deal Breakers
Lack of SDTM or InForm expertise, Less than 6 years of experience in clinical data standards development without an advanced degree, Inability to work in a hybrid U.S. environment
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