Clinical Data Standards Leader — Strategy & Governance

PIERRE FABRE

Occitanie

On-site

EUR 90,000 - 130,000

Full time

3 days ago

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Job summary

Pierre Fabre Laboratories seeks a senior leader to own clinical data standards, governance, and metadata strategy. You will build and maintain a sponsor standards library based on CDISC, collaborate with Data Management, Programming, and Regulatory teams, and drive adoption across CROs and partners.

The role emphasizes hands-on development of standards (eCRF/CDASH, SDTM, ADaM, terminology), alignment with regulatory expectations, and shaping a future data ecosystem for automated analytics and

Qualifications

Advanced degree in life sciences, data management, statistics, programming, or related field.
Minimum 10 years in pharma or CRO/Lab environments.
Hands-on experience developing sponsor data standards (eCRF/CDASH, SDTM, ADaM, terminology).

Responsibilities

Define, implement and govern Clinical Data Standards Strategy.
Own Sponsor Standards Library aligned with CDISC standards.
Lead governance, versioning, change management for study metadata.
Collaborate with DM, Programming, Statistics, Regulatory, Medical Writing and IT.
Deliver training and mentoring on standards and governance.
Support automation and data reuse for submissions and analytics.

Skills

Clinical data standards

Governance & lifecycle

Staff mentoring

Cross-functional collaboration

Education

Master's Degree or PhD in life sciences or related field

Tools

CDISC standards

eCRF/CDASH

SDTM/ADaM

Job description

The role emphasizes hands-on development of standards (eCRF/CDASH, SDTM, ADaM, terminology), alignment with regulatory expectations, and shaping a future data ecosystem for automated analytics and

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