Medical Device/Clinical Affairs Manager

• 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

• 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

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