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Regulatory Submissions
Medical Oversight and Safety:
- Provide medical monitoring for clinical trials, ensuring participant safety and medical oversight throughout studies.
- Review AEs, SAEs, and SUSARs, ensuring timely escalation and regulatory reporting.
Regulatory Compliance and Documentation:
- Support GCP, ICH, and local regulatory compliance, contributing to protocols and study start-up.
- Prepare and review clinical study reports, investigator brochures, and informed consent forms.
Collaboration and Governance:
- Act as a medical contact for investigators and sponsors, addressing safety and protocol questions.
- Participate in safety review meetings and support audit readiness and risk management.
Partner Company
This position is listed on behalf of a partner company that manages all applications and next steps. The role supports global clinical research in a remote working environment with cross-functional collaboration.