Gi Life Sciences Basel
Biel/Bienne
11 hours ago
Medical Device/Clinical Affairs Manager
- 27 May 2026
- 80 – 100%
- Permanent position
- German (Fluent), English (Fluent)
- Biel/Bienne
Introduction
We are looking for Clinical Affairs Managers within the cutting edge Medical Device industry, based in Bern
About the 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
Contact
June RacchiConsultant Life Sciences
Write an email
About the company
Gi Life Sciences Basel
Biel/Bienne
