Clinical Trial Assistant - Eindhoven area
For our partner, an innovative and high-potential Clinical Stage Medical Device company in the Eindhoven area, I am looking for a CTA. As an international company, they’re on a mission to enable natural heart valve restoration through their technology. It’s a young, dynamic, international team that is dedicated to improving patients’ lives through innovation.
As a CTA, you’ll work in a dynamic research and cardiovascular environment towards the clinical realization of their revolutionary products.
- Management, documentation and archiving, TMF maintenance
- Supports preparation of study required documents for submissions to ethic committees and regulatory authorities
- Assists in all clinical and pre-clinical trial related activities
- Keeps track of enrolments, FU-progress, and SAEs
- Supports budget monitoring to make sure costs are on track and approves invoices
- Supports device accountability and shipment of study devices
- Organization of investigators, KOLs or other (study related) meetings
- Support revisions and writing of SOPs
- At least 5 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.
- Excellent Knowledge of Good Clinical Practice (GCP, ISO 14155), SOPs, and Medical Device Regulation
- Excellent knowledge of Microsoft Office, Gmail and/or Outlook
- Works well in a multi-cultural and -disciplinary team
- Ability to manage and prioritize different tasks while still maintaining attention to detail
- Fluent in English (verbal and written) and Dutch at least B2 level
- Ability to work independent and with ownership confidentiality
ORGANISATION AND OFFER
This company is a dynamic research and manufacturing environment working towards the clinical realization of revolutionary products.
They offer a competitive salary and benefits.
INTERESTED? Reach out to Sophie Krakers for more information by contacting +31 (0)20 20 44 502 or email@example.com