Position Details
About this role
Lead development and governance of clinical data and reporting standards to ensure compliance with CDISC and regulatory requirements. Collaborate cross-functionally to define standards, provide feedback on data collection and submissions, and educate the organization.
Key Responsibilities
- Lead cross-functional teams to define data standards
- Ensure clear documentation of standards
- Develop training materials and communicate standards
- Provide feedback on CRF design and SDTM datasets
- Oversee creation of SDTM define.xml and submission guides
Technical Overview
Expertise in CDISC standards including CDASH, SDTM, and ADaM with experience preparing datasets and documentation for FDA and PMDA regulatory submissions. Familiarity with SAS or R programming and clinical trial data standards governance.
Ideal Candidate
The ideal candidate is a senior-level clinical data standards manager with at least 9 years of clinical research experience and expertise in CDISC standards including CDASH, SDTM, and ADaM. They have strong leadership skills, experience preparing datasets for regulatory submissions, and familiarity with SAS or R programming.
Must-Have Skills
Nice-to-Have Skills
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
MS with 9 years or BS with 11 years relevant clinical research experience, Experience leading development of data standards, Experience with at least two CDISC standards, Experience preparing SDTM and/or ADaM datasets for regulatory submissions
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