Clinical Affairs Manager

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Our client is looking for a Clinical Affairs Manager for an immediate start. This is a new and full-time job, you will be either located in our office in Belgium (Kontich) or in Luxembourg (Esch-sur-Alzette) or in Germany. The company is a global, market leading wound care company with sites across UK, Europe and US

Your 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

 

Your profile and qualifications:

  • You hold a university degree in medicine/pharmacy/veterinary medicine/biology or other
  • healthcare related university degreeYou 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.
Permanent
24 September 2020
Pharma
Clinical