Clinical Trial Manager for Medical Device Development

5 days ago


Sligo, Sligo, Ireland beBeeQualityManagement Full time €55,000 - €80,000

Senior Research Manager for Clinical Trials

An exceptional opportunity to manage clinical study activities as part of a clinical team, supporting the development of innovative medical devices in line with international standards and quality management systems.

Job Description:
  • Coordinate clinical investigation activities, maintaining accurate study product logs and inventory records
  • Work collaboratively with site staff, consultants, and teams as needed
  • Order preclinical/clinical supplies when required
  • Assist in designing and writing protocols for preclinical & clinical studies
  • Conduct literature reviews and MAUDE searches for evaluations
  • Create and update Certificates of Expertise and Certificates of Examination
Required Skills and Qualifications:
  • Strong knowledge of Quality Management Systems, Good Clinical Practice, and Good Laboratory Practice for medical devices and clinical studies
  • Understanding of Class III device regulations in EU, US, and globally (ISO 14155 & EU MDR 2017/745)
  • Minimum 5 years' experience in clinical studies for medical devices ideal
  • Cardiovascular experience an advantage
  • Fluent in English (and local language if different)
  • Familiarity with device development from pre-clinical to commercial stage
  • Knowledge of GCP in US & EU
  • High attention to detail
  • Awareness of regulations for feasibility, pivotal & post-market studies, and ability to adjust oversight accordingly
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