- Haute Garonne, France
- On-site
- Full-time · Senior
- 10+ years
Lead the definition, implementation and governance of Pierre Fabre's Clinical Data Standards Strategy, including the CDISC-based sponsor standards library.
Responsibilities
- Lead the definition, implementation and governance of Pierre Fabre's Clinical Data Standards Strategy.
- Own and evolve the Pierre Fabre Sponsor Standards Library built on top of CDISC standards.
- Establish standards governance processes, lifecycle management, version control and change management practices.
- Lead the development, maintenance and governance of standards covering eCRF libraries, SDTM, ADaM, edit checks, controlled terminology and study metadata.
- Ensure Pierre Fabre standards remain aligned with evolving regulatory expectations and industry best practices.
Requirements
- Master's Degree or PhD in life sciences, data management, statistics, programming or a related field