Safety Committee Specialist - Adjudication
Core
Manage day-to-day activities for Clinical Endpoint Committees (CEC) and Data Safety Monitoring Boards (DSMB) in a highly regulated clinical research environment.
Role type
Safety Committee Specialist (Adjudication)
Builds
CEC/DSMB study start-up and close-out activities, electronic adjudication systems, and regulatory-compliant dossiers.
Domain
Clinical Research / Pharmaceutical / Biotechnology
Deliverable
client delivery
Required skills
CEC/DSMB committee processes, therapeutic area knowledge, pathophysiology understanding, dossier compilation, secure data management, regulatory compliance, critical thinking, project coordination
Preferred skills
Microsoft Office proficiency, audit preparation, budget/metrics review, lead capacity operations
Technologies
Electronic adjudication systems, multiple databases, Microsoft Office (Outlook, Word, Excel)
Responsibilities
Initiate CEC/DSMB study start-up activities including charter development and system build; Complete CEC/DSMB close-out activities; Review adjudication publications and information sources to stay updated on regulations; Prepare and QC CEC dossier compilation and submission; Maintain secure files for DSMB unblinded data; Assist with routine project implementation and coordination including presentations and audit preparation.
Seniority
Mid-level, hands-on IC