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# Clinical Data Standards Lead -M - F- CDI H/F

- **Company:** Pierre Fabre
- **Location:** Languedoc-Roussillon, France
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Artificial Intelligence, Computer Programming, Coherent Remote File System (CRFS), Digital Technology, Metadata, Data Management, Software Version Control
- **Published:** November 10, 2026
- **Apply:** https://www.hellowork.com/fr-fr/emplois/85357468.html

## About the Role

· Advanced degree in life sciences, data management, statistics, programming (Master's Degree or PhD) or a related field.

· A minimum of 10 years of experience in the pharmaceutical industry and/or within laboratories (Sponsors) and Contract Research Organizations (CROs).

· Strong experience in clinical trials, ideally in oncology.

· Demonstrated hands-on experience developing and implementing sponsor standards, including eCRF/CDASH, SDTM, ADaM, controlled terminology, metadata and associated submission deliverables.

## Description

We are seeking a highly skilled and proactive Clinical Data Standards Lead to join our Biometry Department.

The successful candidate will serve as the internal representative and owner for clinical data standards, leading the harmonisation and implementation of a company-wide clinical data standards framework, and working closely with Data Managers, Statistical Programmers, Statisticians, Clinical Development, Clinical Operations, Regulatory Affairs, Medical Writing, Data Science, Digital Technology teams, CROs and external partners.

This role offers the opportunity to build a sponsor-owned clinical data standards capability from the ground up, shape the associated metadata and technology ecosystem, and directly influence how Pierre Fabre modernizes clinical development. The successful candidate will have the visibility and mandate to turn standards into a strategic capability supporting quality, submission readiness, automation and data reuse.

Your role within a pioneering company in full expansion:

Clinical Data Standards, Strategy, Governance and Metadata

· 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, including therapeutic-area specific standards where appropriate.

· 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.

· Ensure standards support key submission deliverables, including annotated CRFs, Define.xml and data reviewer guides.

Adoption, Transformation & Collaboration

· Lead the adoption of Pierre Fabre standards across internal teams, CROs and external partners.

· Build strong partnerships with Data Management, Programming, Statistics, Clinical Development, Regulatory Affairs, Medical Writing and R&D IT teams to ensure standards are practical, scalable and operationally efficient.

· Deliver training, coaching and mentoring in clinical data standards and governance.

· Ensure Pierre Fabre standards support future automation, reusable analytics, digital data flow and AI-enabled clinical development processes.

· Represent Pierre Fabre in relevant external standards initiatives, working groups and industry forums., Gestion des données