Xeltis BV is looking for a skilled and driven Clinical Specialist to work in its enthusiastic team, sustaining the clinical realization of Xeltis’ revolutionary restorative medical devices.
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 Clinical Specialist that will collaborate on our ongoing Clinical Trials by building a thorough understanding of our revolutionary restorative medical devices and by supporting their implantation.
- Supporting sites, physicians and other Health Care Professionals (HCPs) with study related procedures and first implants of the Xeltis study devices
- Providing adequate clinical training to the treating physicians and nurses
- Actively collaborating with clinical trial sites and local principal investigators in patient recruitment and selection
- Supporting site identification and selection
- Supporting CROs and/or clinical sites during study start-up, enrollment, follow-up and close-out phase
- Reviewing clinical data and managing SAE documentation and reporting
- Reviewing interim and final reports in close cooperation with the Clinical Affairs team at Xeltis and the CRO
- Collaborating closely with the R&D, QA and Clinical Affairs teams and with external consultants, such as but not limited to CROs and/or core labs
- Professionally collaborating with investigators and other study site HCPs
- Assisting Xeltis’ non-clinical departments in meeting company quality, regulatory, engineering, marketing and sales goals and objectives, as needed and where appropriate
- Providing periodic updates or reports on the current status of clinical trials to senior management
- Managing administration and being responsible for study status reports, essential documents, and accurate study files
- Associate’s or Bachelor’s Degree in nursing, biomedical engineering, or science
- 3+ years’ experience in nursing, physician assistant, cardiopulmonary technician positions
- 2+ years’ experience in clinical specialist positions, with experience with Class III medical devices
- Familiar with European and US regulations, specifically MDR and/or other relevant standards
- Demonstrated leadership and problem-solving skills
- Demonstrated clinical trial enrolment skills a plus
- Experience in preparing and reviewing relevant documentation for ethics committees, competent authorities and regulatory agencies in cooperation with CROs, clinical and regulatory affairs
- Ability to successfully interact with clinical sites, investigators and hospital study nurses
- Excellent communication skills with fluency in English
- Speaking another EU language a plus
- Ability and motivation to travel extensively (>75%)
- Knowledge about clinical studies and relevant regulations/guidelines
The position is full-time. For more information and to submit your CV and motivational letter, please contact: email@example.com