The role includes:
- Evaluation of study feasibility in the country from regulatory perspective
- Regulatory intelligence (tracking recent changes in CT regulations in the country and informing the client thereof, etc.)
- Communication with Regulatory Agency, Ethics Committees as needed, on project and non-project level
- support with clinical trial applications- initial and ongoing; able to compile submission packages under Clinical Trial Directive and Clinical Trial Regulation
- Review and customization of clinical trial documentation to local requirements incl. Informed Consent Forms and other patient documents
Qualifications
- Local regulatory insight
- Experience in the regulatory field of clinical trials of medicinal products (experience with medical devices is a plus)
- Ability to communicate in Danish in English
- Availability around 0,5 FTE
- Preferably located in Denmark
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