Job Description
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...
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