Head of Data Standards & CRF Design (all genders)
Merck KGaA · Warszawa
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- Company
- Merck KGaA
- Location
- Warszawa
- Employment type
- Full-time
- Posted
- July 16, 2026
About this job
This role can be done in a hybrid working model, 3 days from the office in Warsaw Your Role: In your role as Director, Clinical Data Standards and CRF Design, you will lead a global team accountable for clinical data standards, CRF design, metadata governance, and submission-ready data deliverables. You will own the operational implementation of standards across CRF, SDTM, and non-CRF domains, drive governance and version control in the metadata repository, and ensure high-quality study design, eDC CRF Design, and regulatory submission readiness fpr SDTM packages in outsourced studies. You will partner across Clinical Development, Data Management, Biostatistics, Safety, Regulatory, IT, CROs, technology vendors, and industry forums to advance standards, inspection readiness, and digital…
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