Clinical Project Manager – Medical Devices

Excelya>Full-time>Clinical Project Manager – Medical Devices

Job description

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 Project Manager to work for one of our partners, a pharmaceutical group specialised in medical imaging. He/she will be responsible for studies in the field of medical devices at international level.

The activities will be the following:
– Study design
– Drafting of essential documents related to the study: protocol, abstract, patient information note, CRF, letters of intent in collaboration with the experts
– Selection of investigator centres to follow up on selection visits
– Preparation and follow-up of regulatory submissions and amendments: study registration, preparation of forms
– Follow-up of the centres during the course of the study and ensure the opening, monitoring and closing visits of the centres
– Drafting of the final report of the study
– Interpretation and valorisation of study results and participation in the implementation of clinical evaluation files for medical devices
– Monitoring the progress of data entry in clinical research protocols
– Proposal of internal and external communications
– Participation in the clinical strategy and clinical evaluation of devices

Profile:

  • You have a minimum of 5 years of scientific, health engineering, medical or pharmaceutical education.
  • You have a minimum of 3 years experience in clinical investigations, ideally in the medical devices sector.
  • You have experience in medical devices and associated regulations: ISO 14155, MedDev, MDR 2017/745.
  • You have good interpersonal, writing and organisational skills.
  • You are fluent in Good Clinical Practice and speak English fluently.

 

Summary

Contact

Apply for this job