Responsibilities

• 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

Qualifications

• 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...