DM Programmer

As SDTM & CRF Design Lead you will oversee end-to-end SDTM activities on a sponsor-dedicated project. You will manage CRF design from the protocol, validate vendor specifications, and define SDTM specifications across studies. You’ll collaborate with sponsor, CRO partners, and internal teams to ensure compliant SDTM data delivery while supporting audits and inspections. This role offers remote work within Europe or South Africa, with a focus on data standards, quality, and cross-functional collaboration to drive trial efficiency.

• Collaborate with Sponsor colleagues and CRO Partners to review CRF design and SDTM compliance
• Plan data receipt and oversight for assigned clinical trials with Study Data Leads
• Program reports and standardize data review/analysis processes for vendors and internal teams
• Perform SDTM data analyses and oversee SDTM data quality and completeness
• Review SDTM annotations and datasets to ensure consistent data standards
• Map SDTM data and manage annotated CRF
• Attend cross-functional meetings with Mission, Submission, Project, JCST, DEM, Biometrics, CRST teams
• Conduct quality checks and create edit checks for new CRF modules; share outputs
• Support audits and inspections as required
• Engage in other duties as assigned by the Company

• At least 5 years of SDTM and/or CRF design experience
• Experience with Biometrics processes: review of SDTM annotated CRFs, writing/reviewing technical specifications, log review and error resolution
• Data mapping experience and SDTM Controlled Terminology
• SAS programming experience and SDTM deliverables
• Clinical or pharmaceutical field experience; Data Management background
• Experience with relational databases and EDC systems
• Advanced reporting tool familiarity
• Strong knowledge of FDA/Regulatory GCP and GCDMP
• Excellent English communication skills

• strong communication
• cross-functional collaboration
• attention to detail
• SDTM
• CRF design
• SDTM annotations