Senior Study Coordinator

Excelya>Full-time>Senior Study Coordinator

Job description

Founded in 2014, Excelya is a “people centered” contract research organization (CRO).

We offer a personal and authentic experience within an ambitious young healthcare company on its way to becoming the leader in clinical research in Europe with our 800 Excelyates. Our unique one-stop provider service model – leveraging a full-service, functional service provider and consultancy – allows our Excelyates to evolve across a wide range of projects. Working with leading experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means enjoying a challenging professional environment that encourages personal, intellectual and operational participation so that together we can be the best in our field. We are committed to empowering each Excelyate to express their natural talents, develop their full potential and invest in our unique project.

Missions

For your first mission, you will be involved in a national and international context in the coordination of clinical studies within the teams of one of our clients, a recognized player in the field of medical devices and drugs.

You will be in charge of the coordination of logistical, regulatory and quality aspects of the trials. You will participate in:

  • To the attention of the Competent Authorities & Ethics Committees: preparation and follow-up of submission/amendment files and clinical reports for medical research
  • For the CNOM, CNIL, EudraCT, ClinicalTrial.Gov: preparation and follow-up of administrative and regulatory procedures for trials and publication of trial results
  • Drafting in English/French of the specific documents of the Trials (specifications of the “Contract Research Organizations” (CROs) partners, patient information/ consent form, patient card, patient observation booklets, etc.)
  • Drafting in English/French of administrative documents for the trials (confidentiality agreements, single agreements, contracts and/or amendments with CROs, health institutions, private practices, experts……)
  • Entering contracts and amendments into the dedicated database in collaboration with the legal department
  • Organizing, preparing and coordinating meetings of the trial project teams, including drafting the minutes
  • Ordering and follow-up of activities/materials/medical devices/products for the trials
  • Selection and qualification visits of CROs
  • Selection, feasibility and qualification of investigation centers
  • Budgetary follow-up of medical research through regular input of invoices upon receipt
  • Regular quality control of trial documents until archiving
  • Management of electronic and paper Trial Master Files (TMFs)
  • Monitoring of investigation centers to optimize the conduct of trials in terms of data quality (co-monitoring, motivational visits, quality control)

Profile

  • 8 to 10 years minimum of experience in a pharmaceutical/Biotech laboratory
  • Good communicator, team player and autonomous
  • Good level of written and spoken English
  • Experience in chronic diseases (hypertension, CKD, diabetes)
  • Experience in RIPH & non-RIPH drug & medical device studies
  • Strongly valued experience in gas studies
  • Experience with data protection and patient privacy is highly valued

Summary

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