(Junior) Manager Clinical Trials Medical
Core
Ensuring compliance of clinical trials with safety regulations, coordinating with CROs and investigators on adverse events, and developing safety/medical monitoring plans.
Role type
Junior Manager Clinical Trials Medical
Builds
Clinical trial safety monitoring and regulatory compliance for a cannabinoid-based chronic pain treatment.
Domain
Biopharma / Clinical Research / Pain Management
Required skills
Medical degree, clinical research experience, CRO/investigator coordination, data analysis (Excel), protocol development, safety reporting
Preferred skills
Experience with eCRF/eDiary/AE reports, audit execution, stakeholder presentation
Technologies
eCRF, eDiary, Excel
Responsibilities
Ensure clinical trial compliance with safety regulations, coordinate with CROs and investigators on adverse events and protocol deviations, develop safety and medical monitoring plans, conduct medical audits of clinical data, contribute to protocol and consent document creation, collaborate with data management on safety data reporting, create and review study plans and annual safety reports
Seniority
Junior, hands-on IC with early leadership responsibilities