About this role

Ensure scientific support for operational realization for assigned study/studies or registries
Contribute to preparation and/or review of documents requiring scientific background
Participate in Study Team and monitoring team training on medical information
Support CRD in preparation of medical answers to questions from Health Authorities
Ensure quality and update of study documents, CRF adequacy with protocols/protocol amendments
Review and assess adverse events and protocol deviations
Assist in preparation of safety reports and regulatory submissions
Communicate effectively with CRD and study team on potential safety signals or study risks

Advanced degree (PharmD, PhD, or Master's degree) in life sciences, pharmacy, or related field
1-2 years of clinical development experience in pharmaceutical/biotech industry preferred
Strong knowledge of GCP, ICH guidelines, and regulatory requirements (FDA, EMA)
Understanding of clinical trial processes and adverse event reporting

Clinical Scientist

Key skills