Clinical Affairs Specialist - UK

Job Description

The company: This position is with an international, innovative, family-owned company who is one of Europe's leading wound care and dermatology companies from research and development to delivering unique products that are clinically proven to the healthcare market. They specialise in a dependable and unique dressing designed to simplify wound care for a large variety of wound conditions. Over the course of just a few years, they have gained the leading position in their home market, and are working towards achieving this on an international level. The company’s success is based on the dedication of their people and their safe and easy-to-use product portfolio which combines innovation with significant progress in wound care. 

The position:  In order to support their fast-growing business in the field of wound management, they are looking for a Clinical Affairs Specialist for an immediate start in the clinical division of the company. You will be located in the UK (Home-Office based). 

Why should you apply?

• Excellent working conditions.
• An innovative and inspiring work environment.
• Independent project work & responsibilities within a professional team.
• Career prospects.
• Learning and development opportunities.
• Competitive remuneration according to experience.

Basic Salary: £40,000 - £50,000 (dependent on experience)

Area Working: Home based (UK)

Products: Wound Care - Advanced Skin Healing

Your experience:

• You will hold a university degree in medicine/pharmacy/veterinary medicine/biology or other healthcare related university degree
• You have experience in the field of clinical affairs for medical devices
• You have already been in contact and/or 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. Other languages such as e.g. German or Dutch would be an asset.

The role:

• Support the management and coordination of conduct of PMCF (post market clinical follow up)/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 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;
• Support 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 .

Benefits:

• Car
• Pension
• Healthcare
• 25 Days Holiday
• Mobile, LA, Lap Top