Who we are ?
We are Pierre Fabre Laboratories, a global leader combining pharmaceutical expertise with dermo-cosmetics to support consumers and patients at every stage of their care journey.
Our portfolio includes several medical franchises and international brands such as Eau Thermale Avène, Ducray, A-Derma, Klorane, René Furterer, and Pierre Fabre Oral Care.
By joining us, you become part of a meaningful company where the human dimension is essential. You become a participant in the "We Care Movement," a movement that values excellence and innovation within passionate teams. Together, we push the boundaries of science to unite health and beauty for the benefit of all, because Every time we care for a single person, we make the whole world better.
Present in 120 countries with a team of over 10,000 employees, we are proud to create a scientific and human impact, today and tomorrow! If caring is at the heart of your values, join Pierre Fabre Laboratories and become a key player in the “We Care Movement".
Your mission
We are looking to hire a Clinical Study Coordinator on a permanent contract, based in Toulouse or Boulogne.
Clinical Study Coordinator: participate in the management of clinical trials through the activities delegated by the CSMs:
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Support the CSM in coordinating clinical trial team to successfully conduct required activities.
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Ensure the follow-up of actions defined during clinical trial team meetings.
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Participate in the drafting/review of clinical trial documents (e.g. Informed Consent forms (ICFs), protocol, protocol amendments, safety management plan).
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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)
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Request and monitor clinical trial insurance.
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Participate to the review of the regulatory package submission.
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Actively contribute that the clinical trials are performed according to the GCP, standard operational procedures, and in compliance with Pierre Fabre ethical rules.
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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…).
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Contribute to the logistical follow-up of clinical trial materials.
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Support in setting up a clinical trial oversight plan with internal stakeholders.
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Assist in organizing key meetings related to the clinical trials, including drafting and distribution of meeting minutes
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Participate in budget monitoring of clinical trial (e.g. invoices check, update of budget trackers).
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Ensure the update of tools and dashboards for clinical trial management.
Trial Master File Management:
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Ensure that the TMF is inspection-ready throughout the clinical trial in compliance with GCP by ensuring quality checks.
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Ensure the creation, classification, and archiving of the Trial Master File according to the current procedure.
Who you are ?
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.
At Pierre Fabre Laboratories, we believe that our greatest asset is our people.
We are committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identify, and maintain employment statistics on applicants. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process. Thus, we commit to considering all applications equally, without fail.