Clinical Trial Assistant

Xeltis is looking for a Clinical Trial Assistant to provide logistics and operational support to clinical studies and clinical project management.

Xeltis is a clinical stage medical device company with the world’s most advanced polymer-based platform of restorative cardiovascular devices. Xeltis’ devices naturally evolve into living blood vessels or heart valves within the body through patient’s own tissue.

The company has a young team of 40 employees from all over the world. “Improving patients’ lives” is what drives us to work with joy on a daily basis.

Who are we looking for?

We are looking for a prompt and organised individual willing to contribute to the successful management of several international clinical trials of the most advanced restorative cardiovascular devices. The Clinical Assistant will work within the clinical and medical affairs team. The position is (partially) office-based in Eindhoven, The Netherlands.

Job function/Activities:

  • Preparing materials for and participating in internal project meetings for note taking and documentation of action items
  • Assisting in all clinical and pre-clinical trial related activities
  • Arranging travels for team members
  • Updating the list of study site members for each study
  • Managing, documenting, archiving and maintaining the Trial Master File
  • Supporting preparation of study required documents, for submissions to ethic committees and regulatory authorities
  • Keeping track of enrolments, FU-progress, and SAEs
  • Supporting budget monitoring to make sure costs are on track and invoices approved
  • Supporting device accountability and shipment of study devices
  • Shipping multiple study related materials and documents
  • Organizing investigators, KOLs or other (study related) meetings
  • Tracking study insurance
  • Tracking study agreements and contracts
  • Preparing regular updates and providing assistance for study reports
  • Supporting revisions and writing of SOPs

Knowledge and skills:

  • Excellent knowledge of Good Clinical Practice (GCP, ISO 14155), SOPs, and Medical Device Regulation
  • Excellent knowledge of Microsoft Office, Gmail and/or Outlook
  • Work well in a multi-cultural and multi-disciplinary team
  • Good communicator
  • Ability to manage and prioritize different tasks while still maintaining attention to detail
  • Fluent in English (oral and written) and at least one other language
  • Ability to work independently, with ownership and confidentiality

Education:

MBO according to Dutch education system or equivalent (preferred, but not necessary).

Experience:

At least 2 years in an equivalent position in a biomedical context (industry, care facility or service provision) or justify having worked in the field of clinical research in a similar position.

The position is full-time. For more information and to submit your CV and motivational letter, please contact: recruitment@xeltis.com

Working at Xeltis

At Xeltis, we recognize that people make a difference. We are a young, dynamic, international team of 40 professionals dedicated to improving patients’ lives through innovation.
To submit your CV and motivational letter, please contact: recruitment@xeltis.com

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