Clinical Study Manager

Excelya>Full-time>Clinical Study Manager

Description de l'emploi

Established 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-shop 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.

 

Mission:

We are looking for a Clinical Study Manager to work from home on behalf of one of our leading pharmaceutical partners. You will be responsible for the following tasks for international pharmaceutical and oncology trials

  • Ensure regulatory filings and coordinate the planning of clinical study submissions (including the preparation of documents required for PPC submissions)
  • Supporting CRAs and Clinical Project Managers in the set-up and follow-up of studies, by organising the preparation of documents and local and international meetings
  • Administrative and regulatory follow-up of clinical studies (protocol, case report forms, submission documents)
  • Setting up monitoring tables and updating data in the database
  • Organisation of and participation in internal and national study monitoring meetings
  • Preparation, filing and archiving of the eTMF

Profil :

  • Titulaire au minimum d’un niveau bac + 5 cursus scientifique, d’ingénierie de la santé, médecine ou pharmacie
  • Vous disposez d’une expérience de 3 ans minimum en investigations cliniques, idéalement dans le secteur des dispositifs médicaux
  • Vous avez une expérience dans les dispositifs médicaux et la réglementation associée : ISO 14155, MedDev, MDR 2017/745
  • Vous avez de bonnes capacités relationnelles, rédactionnelles et organisationnelles. Vous maîtrisez les Bonnes Pratiques Cliniques et parlez anglais couramment

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