Manager d'Etudes Cliniques- CDI- H/F

Qui sommes-nous ?

Nous sommes les Laboratoires Pierre Fabre, leader mondial qui allie expertise pharmaceutique et dermo-cosmétique pour accompagner les consommateurs et les patients à chaque étape de leur parcours de soins.Notre portefeuille compte plusieurs franchises médicales et marques internationales dont Eau thermale Av\u00c8ne, Ducray, A-Derma, Klorane, René Furterer et Pierre Fabre Oral Care.En nous rejoignant, vous int\u00e9grer une entreprise riche de sens, où la dimension humaine est essentielle. Vous devenez acteur du "We Care Movement", un mouvement qui valorise l'excellence et l'innovation au sein d'équipes passionn\u00e9es. Ensemble, nous repoussons les limites de la science pour unir sante et beaut\u00e9 au bénéfice de tous, car \u00e0 chaque fois que nous prenons soin dune seule personne, nous rendons le monde meilleur.Pr\u00e9sents dans 120 pays et une équipe de plus de 10 000 collaborateurs, nous sommes fiers de cr\u00e9er un impact scientifique et humain, aujourd'hui et demain! Si prendre soin est au c\u00f4ur de vos valeurs, rejoignez les Laboratoires Pierre Fabre et devenez un acteur \u00e9l\u00e9ment du "We Care Movement".

Votre mission

The Clinical Operations Team from Pierre Fabre Pharma R& D is recruiting a Clinical Study Manager (CSM) either based in Boulogne-Billancourt (Paris area) ou en Toulouse (South-West of France).

Pierre Fabre sponsors international interventional clinical trials from Phase I (first-in-human) to Phase IV across its key therapeutic areas: primarily oncology, dermatology, and rare diseases.

You will join a team of around 18 people led by the Director of Clinical Operations and will be responsible for the set-up and conduct of assigned clinical studies.

You will lead Clinical Trial Teams and coordinate all internal and external stakeholders to ensure study delivery in line with quality, cost, and timeline objectives.

Votre r\u00f4le au sein d'une entreprise pionni\u00e8re en pleine expansion :

• Acting as Project Manager for your studies, coordinating and supervising internal teams and external vendors (CROs) using appropriate project management and performance monitoring tools (e.g. risk matrix, responsibility matrix, key performance indicators, communication plan, monitoring plan, etc...).
• Overseeing study feasibility and budget estimates prepared by CROs, with support from Outsourcing Managers.
• In collaboration with the Director of Clinical Operations, within the framework of study outsourcing: defining and preparing, together with Outsourcing Manager, all performance indicators and oversight tools used to monitor vendor's activities and reporting to management and Outsourcing Manager any deviations or non-compliance observed with regards to contractual commitments.
• Contributing to protocol in close collaboration with the Medical writer as well as developing study documents.
• Leading the Clinical Trial Team for your assigned studies.
• Ensuring studies are optimised and controlled in terms of cost, timelines, quality, and risk management, and proposing corrective actions when required along with monitoring their implementation.
• Ensuring full compliance with Good Clinical Practice, internal procedures, and Pierre Fabre ethical standards.
• Supervising study administrative and document management activities performed by Clinical Study Coordinators.
• Reporting study progress and budget status to project and clinical operations management.
• Acting as a mentor and reference for junior Clinical Study Managers.

The role involves occasional national and international travels.

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 \u00eatre-vous ?

Your skills at the service of innovative projects:

• You hold a postgraduate scientific degree (Masters level or equivalent) in medicine, pharmacy, or another scientific discipline, and have at least 5 years experience managing international clinical trials.
• Experience in oncology would be an asset.
• You have a proven track record of successful collaborations with international CROs on strategic, project-based studies and have a strong understanding of the clinical regulatory and quality environment.
• You are fluent in English, both spoken and written.

La premi\u00e8re richesse des Laboratoires Pierre Fabre, sont les femmes et les hommes qui les composent disant M. Pierre Fabre.Fiers de cet héritage, et convaincus que la diversité des parcours, des exp\u00e9riences et des identit\u00e9s renforce notre performance collective, nous nous engageons \u00e0 promouvoir l\u00e9galit\u00e9 des chances et \u00e0 garantir un environnement inclusif pour tous. Dans le respect des lois en vigueur, toutes les candidatures sont étudi\u00e9es avec la même attention, sans distinction d'origine, de sexe, dâ...

Type de contrat

Type de contrat CDI

Contrat travail Dur\u00e9e du travail Travail en journ\u00e9e

• Qualification : Cadre