Clinical Project Manager

Excelya>Full-time>Clinical Project Manager

Job description

Created in 2014, Excelya is a 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

Mission
The Project Manager is responsible for the conduct of all clinical aspects of the assigned studies, from initiation to completion.
In compliance with regulatory requirements, the Project Manager will perform the following tasks

  • Set up and review of clinical study documentation, including study protocol, abstract, information letter and consent, case report book, newsletter, and any other documents that support or enhance the conduct of clinical studies;
  • Supervision and management for each clinical study of regulatory submissions and authorizations, training of the project team, coordination of the investigation centers, monitoring of the study budget, conduct of monitoring visits etc.
  • Updating procedures in accordance with current regulations. This includes the creation of new procedures and tools as needed.
  • Follow-up of objectives, regular reporting of activities to the direct supervisor.

Profile:

The assignment requires the following skills:

  • Experience in the overall management of clinical projects in the medical device industry

  • Management of a multidisciplinary project team

  • Excellent oral and written communication/presentation skills.

  • Excellent organizational skills, analytical mind, rigor and autonomy

  • Good computer skills

  • Team spirit, adaptability, commitment

  • Fluency in English (written and oral communication).

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