Gi Life Sciences Basel
Biel/Bienne
Vor 14 Stunden
Medical Device/Clinical Affairs Manager
- 27 Mai 2026
- 80 – 100%
- Festanstellung
- Deutsch (Fliessend), Englisch (Fliessend)
- Biel/Bienne
Einführung
We are looking for Clinical Affairs Managers within the cutting edge Medical Device industry, based in Bern
Über den Job
Tasks
- Planning, execution, and management of clinical studies from A to Z
- Preparation and review of all types of clinical study documents
- Preparation and submission of dossiers to ethics committees and competent authorities
- Monitoring study progress, including site initiation, patient recruitment, monitoring visits, and documentation
- Independent conduct of on-site monitoring activities
- Analysis of clinical study data
- Maintenance of the EDC system and management of study-related documentation
- Participation in PMCF processes, including planning, execution, and reporting
- Ensuring compliance with GCP, GMP, GDP, and other regulatory requirements
Profile
- MSc in Biomedical Sciences or a comparable qualification with at least 2 years of experience in Clinical/Medical Affairs (Sponsor or CRO), or a PhD with initial professional experience in clinical research
- Experience in clinical trial management
- Basic knowledge of biostatistics
- Experience in the medical device industry, ideally in ophthalmology, as well as knowledge of the relevant regulatory environment
- Good command of English and German (minimum B2/C1 level in both)
- Independent, structured, and solution-oriented working style
- High level of initiative and strong time management skills
- Team player with enthusiasm for interdisciplinary collaboration and an understanding of the perspectives and requirements of other departments
Kontakt
June RacchiConsultant Life Sciences
E-Mail schreiben
Über das Unternehmen
Gi Life Sciences Basel
Biel/Bienne
