The Clinical Data Manager (a) will accompany and drive the phase 3 drug development by:
- Ensuring Data Management activities comply with internal standards and regulatory requirements
- Supporting the development and testing of (e)CRFs and data review tools
- Contributing to the creation of Data Management documentation
- Performing data review, discrepancy and query management, and protocol deviation tracking
- Assisting in database lock activities and providing metrics to the Project Data Manager
- Archiving study documentation in accordance with guidelines
To be considered for this role, you must bring:
- Bachelor's degree or higher in a pharmaceutical or biomedical discipline (e.g., Biological
- Sciences, Pharmacology)
- Minimum 2 years of experience in Clinical Research or Clinical Data Management within the Pharmaceutical or Biotech industry
- Solid understanding of clinical trial databases, data flow, and (e)CRF design
- Familiarity with ICH-GCP and international clinical research regulations
- Strong organizational skills and a collaborative mindset
- Fluency in written and spoken English
The selected candidate will be part of a dynamic team in an international environment and actively contribute to shape, develop, and drive the market authorization of innovative drugs. Hybrid work model. Extension or take-over possibility.