eTMF Trailblazer: Global Trial Docs & Compliance

Pierre Fabre Laboratories; Boulogne-Billancourt; Hybride; EUR 65 000 - 85 000; Plein temps

Avantages offerts par ce poste

Profit sharing

Shareholding plan

Health insurance

Transport allowance

Paid holidays

Résumé du poste

Pierre Fabre Laboratories is hiring a permanent eTMF Specialist to join the R&D Medical Care department in Toulouse or Boulogne. You will oversee the eTMF system to ensure regulatory compliance, quality control, and inspection readiness across global clinical trials.

The role requires expertise in clinical trial documentation management, cross-functional collaboration, and active participation in audits and inspections. Remote work is possible up to 2 days per week after the trial period.

Qualifications

• Minimum 5 years in clinical trial documentation management.
• 3+ years in an eTMF-focused role.
• Strong knowledge of ICH/GCP, regulatory standards and TMF lifecycles.
• Experience with TMF metrics, KPIs and dashboards.

Responsabilités

• Oversee setup, maintenance and closeout of eTMFs across trials.
• Monitor document completeness and compliance; ensure inspection readiness.
• Provide SME training and develop SOPs/templates for eTMF.
• Support audits/inspections and collaborate with CROs and internal teams.
• Coordinate system migrations and validation activities with IT.

Connaissances

eTMF management

Regulatory compliance

Quality control

Cross-functional collaboration

Audit support

Formation

Bachelor's or Master's in health sciences

Outils

Veeva Vault

Description du poste

Pierre Fabre Laboratories is hiring a permanent eTMF Specialist to join the R&D Medical Care department in Toulouse or Boulogne. You will oversee the eTMF system to ensure regulatory compliance, quality control, and inspection readiness across global clinical trials.

The role requires expertise in clinical trial documentation management, cross-functional collaboration, and active participation in audits and inspections. Remote work is possible up to 2 days per week after the trial period.