Clinical Affairs Manager – Medical Devices – UK wide, Home based
**This company will interview, offer and onboard remotely**
A multinational medical device company that have been steadily expanding are seeking a Clinical Affairs Manager to work with their wound care/dermatology portfolio. They have a track record of developing their employees through the business with clear succession plans for each role.
- 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 a fast-growing business in the field of wound management I am looking for a Clinical Affairs Manager for the earliest possible date in the clinical division of a multi-national medical device company. You will be based in the UK, remote based.
- 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
To apply for this role as Clinical Affairs Manager –our client is hoping for someone with the following skills and experience
- 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.
What should you do next?
Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there.
Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.