Clinical Affair Specialist

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
• 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 Specialist for the earliest possible date in the clinical division.

Your missions:

• 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.