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Job Details
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Clinical Affairs Manager (Home Based)

Business Type: Medical Devices Company
Job Type: Clinical Development, Clinical - Drug Safety, Clinical Research Associate (CRA), Clinical Study- Trials, Clinical Supplies
Job Level: Experienced (non manager)
Position: Full Time
Salary: EUR60000 - EUR65000 per annum
Location: Germany
Reference: 260882
Closing Date: 01/10/20
Job Details:

My client 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, they 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.

My client is looking for a Clinical Affairs Manager for an immediate start. This is a new and full-time job for which they initially offer a short-term contract with the possibility to become permanent. The candidate will be either located in their office in Belgium or in Luxembourg or in Germany (Home- Office based).

What they offering:

  • 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

Candidate''s responsibilities:

  • 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

Candidate''s profile and qualifications:

  • You hold a university degree in medicine/pharmacy/veterinary medicine/biology or other healthcare related university degree You 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.

If you are interested or know anyone who is, feel free to send your or their CV to alternatively give me a call on +49 892 109 3363 extension 3330

Posted: 17/09/2020 | NPJ Ref: 258534
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