Flen Health is an international, innovative, family-owned company based in Luxembourg, Belgium, the Netherlands, Germany and the UK.
Over the course of just a few years, Flen Health have gained the leading position in their home market, namely the Belgian wound care market and are working towards achieving this on an international level. Our company’s success is based on the dedication of our people and our safe and easy-to-use product portfolio which combines innovation with significant progress in wound care and is inspired by our motto. We help you to ‘live the life you love’.
We are looking for a Clinical Affairs Manager for an immediate start. This is a new and full-time job for which we initially offer a short-term contract with the possibility to become permanent. You will be either located in our office in Belgium (Kontich) or in Luxembourg (Esch-sur-Alzette) or in Germany (Home- Office based).
What we offer:
- Excellent working conditions
- An innovative and inspiring work environment
- Independent project work & responsibilities within a professional team
- Career prospect
- Learning and development opportunities
- Competitive remuneration according to experience
In order to support our fast-growing business in the field of wound management we are looking for a Clinical Affairs Manager for the earliest possible date in the clinical division of Flen Health.
- Management and coordination of conduct of PMCF/clinical trials with a focus on medical devices including the planning, start-up, progress and closure; and to maintain quality and integrity of study data in accordance with protocol, company SOPs, applicable laws (MDR/MDD), standards (ICH-GCP, ISO 14155) and guidelines;
- Review, preparation, coordination and follow-up of CT submissions to ethics committees and competent authorities
- Assurance that clinical trial projects are properly resourced, managed and executed according to established objectives, budget and timelines;
- Manage the day-to-day clinical operations, including management of vendors (e.g. CRO) and coordination of activities;
- Pro-active identification of project specific issues and set up strategies to handle this efficiently;
- Support/lead of feasibility assessments and selection of countries and sites for clinical studies;
- Proactive collaboration with investigators/study team;
- Provision of feedback to the clinical line manager regarding study progress
Your profile and qualifications:
- You hold a university degree in medicine/pharmacy/veterinary medicine/biology or other healthcare related university degreeYou cumulate several years of experience in the field of clinical affairs for medical devices
- You have already been responsible for or have supported the conduct of clinical investigations/PMCF
- You have in-depth knowledge of the applicable legislations of international markets and the necessary standards
- You are pragmatic, proactive, problem- solving and looking for initiative
- You have excellent time management, presentation, interpersonal communication skills especially with relevant authorities, consultants/CROs and experience in project management
- You are fluent in English. German or Dutch would be an asset.
Are you interested in working with an ambitious and highly dedicated team?
Please send your CV and covering letter by using the form below: