
Clinical Trial Manager for Medical Device Development
5 days ago
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
- 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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