Clinical study coordinator - cdi- h/f

Qui sommes-nous ?

Pierre Fabre est le 2ème laboratoire dermo-cosmétique mondial, le 2ème groupe pharmaceutique privé français et le leader des produits vendus hors prescription dans les pharmacies en France.

Son portefeuille compte plusieurs franchises médicales et marques internationales dont Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive et Pierre Fabre Oral Care.

Implanté depuis toujours en région Occitanie, fabricant plus de 95% de ses produits en France, le groupe emploie près de 10 000 collaborateurs dans le monde et distribue ses produits dans quelque 130 pays. Pierre Fabre est détenu à 86% par la Fondation Pierre Fabre, une fondation reconnue d’utilité publique, et secondairement par ses collaborateurs à travers un plan d’actionnariat salarié.

En 2021, Ecocert Environnement a évalué la démarche de responsabilité sociétale et environnementale du Groupe selon la norme ISO 26000 du développement durable et lui a attribué le niveau « Excellence ».

Pierre Fabre est reconnu comme l’un des « Meilleurs Employeurs du Monde 2021 » par Forbes. Notre groupe est classé dans le Top 6 de l’industrie cosmétique et dans le Top 7 de l’industrie pharmaceutique dans le monde. Nous sommes convaincus que notre engagement et notre passion font préserver notre indépendance et vivre notre raison d'être.


Votre 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...


Qui êtes-vous ?

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.

Nous sommes convaincus que la diversité est une source d’épanouissement, d’équilibre social et de complémentarité pour nos collaborateurs, nos offres sont donc ouvertes à toutes et tous sans restriction.