eTMF Specialist- CDI - H/F

Pierre Fabre

  • Boulogne-Billancourt, Hauts-de-Seine
  • CDI
  • Temps-plein
  • Il y a 3 jours
Who we are ?Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive, Pierre Fabre Oral Care.Established in the Occitanie region since its creation, and manufacturing over 95% of its products in France, the Group employs some 10,000 people worldwide. Its products are distributed in about 130 countries. 86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation, a government-recognized public-interest foundation, while a smaller share is owned by its employees via an employee stock ownership plan.In 2019, Ecocert Environment assessed the Group’s corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the “Excellence” level.Pierre Fabre is recognized as one of the "World's Best Employers 2021" by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide.Your missionWe are hiring a permanent eTMF Specialist in Toulouse or Boulogne to join a team of 7 people under the hierarchical and functional responsibility of the Clinical Study Coordinators Manager in the R&D Medical Care department.The eTMF Specialist plays a vital role within the Clinical Development Platform by overseeing the electronic Trial Master File (eTMF) system to ensure regulatory compliance, quality control, and inspection readiness across global clinical trials. This position requires expertise in clinical trial documentation management, collaboration with cross-functional teams, and active participation in audits and inspections.Your role within a pioneering company in full expansion:
  • Key responsibilities in eTMF management:
The specialist manages the setup, maintenance, and closeout of eTMFs, performs regular quality control checks, monitors metrics and KPIs to ensure document completeness and compliance, and approves TMF management plans for internal teams and CROs. They also handle archive management to maintain accessible and organized records.
  • Subject Matter Expert role:
They serve as the SME by providing training and support on eTMF best practices, developing and revising related SOPs and templates, and acting as the main contact for eTMF-related queries from users, auditors, and other stakeholders.
  • IT system oversight and compliance:
The specialist ensures compliance with validation requirements, manages system migrations and updates, creates and manages study access, assesses the impact of new system versions, and supports problem resolution and system evolution in collaboration with IT teams.DIMENSIONS, CONTEXT AND IMPLICATIONS OF THE JOBThe clinical trials are mainly international and covered the therapeutic areas from Pierre Fabre portfolio, namely oncology, dermatology and rare diseases.A high level of quality and accuracy is expected by the eTMF specialist.This position is compatible with teleworking up to 2 days a week after the trial period.We offer an attractive remuneration/benefits package: Incentives, profit-sharing, Pierre Fabre shareholding with matching contribution, health and provident insurance, 16 days of holidays (RTT) in addition to 25 days of personal holidays, public transport participation, very attractive CE...Who you are ?Your skills at the service of innovative projects:
  • Bachelor’s or master’s degree or equivalent in a health sciences, life sciences or a related field.
  • Minimum 5 years of experience in clinical trial documentation management, with at least 3 years in an eTMF-focused role.
  • Hands-on experience with TMF Veeva Vault and other Veeva environments.
  • Strong knowledge of ICH/GCP, guidelines, quality standards and regulatory requirements.
  • Strong understanding of the DIA TMF Reference Model and clinical trial documentation lifecycles.
  • Knowledge of internal stakeholders’ expectations (biometry, medical, quality assurance, clinical development, pharmacovigilance, etc…).
  • Experience with TMF metrics, KPIs, and dashboards.
  • Experience in vendor oversight and CRO collaboration are advantageous.
  • Fluent English (oral and written).
We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.

Pierre Fabre