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...