Up to 50,000 GBP per year
Clinical Affairs Specialist (M/F)
My client is looking for a Clinical Affairs Specialist for an immediate start. This is full-time and permanent position.
You will be located in the UK (Home-Office based), Belgium (Kontich) or Luxembourg.
What the client offers:
•Excellent working conditions
•An innovative and inspiring work environment
•Independent project work & responsibilities within a professional team
•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 Specialist for the earliest possible date in the clinical division.
•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 will hold a university degree in medicine/pharmacy/veterinary medicine/biology or other healthcare related university degree
•You will have accumulated 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 inventive
•You have excellent time management, presentation, interpersonal and communication skills, especially with relevant authorities, consultants/CROs and will have experience in project management
•You are fluent in English. German or Dutch would be an asset.