Medical Device/Clinical Affairs Manager

We are looking for Clinical Affairs Managers within the cutting edge Medical Device industry, based in Bern
Medical Device/Clinical Affairs Manager
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 jidd5c609aa jit0623a jiy26a