Job Description

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 mission

We are looking to hire a Clinical Study Coordinator on a permanent contract, based in Toulouse (31, Langlade site, Oncopole) or Boulogne-Billancourt.

Your role within a pioneering company in full expansion:

Clinical Study Coordinator: participate in the management of clinical trials through the activities delegated by the Clinical Study Manager:

• Support the CSM in coordinating clinical trial team to successfully conduct required activities and ensure the follow-up of actions defined during clinical trial team meetings.
• Participate in the drafting/review of clinical trial documents (e.g. Informed Consent forms (ICFs), protocol, protocol amendments, safety management plan).
• Contribute to the development of regulatory and administrative documents, ensuring their follow-up and updates (e.g. training log, TMF management plan, trial document inventory and change control)
• Request and monitor clinical trial insurance.
• Participate to the review of the regulatory package submission.
• Actively contribute that the clinical trials are performed according to the GCP, standard operational procedures, and in compliance with Pierre Fabre ethical rules.
• Actively participate in CRO oversight (e.g. by defining and preparing performance indicators for subcontracted activities, reviewing CRO reports, reviewing the monitoring visit reports, etc…).
• Contribute to the logistical follow-up of clinical trial materials.
• Support in setting up a clinical trial oversight plan with internal stakeholders.
• Assist in organizing key meetings related to the clinical trials, including drafting and distribution of meeting minutes
• Participate in budget monitoring of clinical trial (e.g. invoices check, update of budget trackers).
• Ensure the update of tools and dashboards for clinical trial management.

Trial Master File Management:

• Ensure that the TMF is inspection-ready throughout the clinical trial in compliance with GCP by ensuring quality checks.
• Ensure the creation, classification, and archiving of the Trial Master File according to the current procedure.

This position is compatible with teleworking up to 2 days a week according to company rules.

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...

Who you are ?

Your skills at the service of innovative projects:

You hold a Bachelor’s degree (or equivalent) with specialized training as a Clinical Research Associate or in a health-related field.

Ideally, you have at least 5 years’ experience in clinical research.

Fluency in spoken and written English is essential.

Experience or initial knowledge in oncology would be a plus.

Familiarity with the TMF index and, in particular, with the Veeva solution, as well as with the latest international regulations, would be a strong asset.

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.