Senior Safety Committee Specialist - Adjudication
Core
Lead complex safety projects and ensure successful implementation of pharmacovigilance practices for Clinical Evaluation Committees (CEC) and Data and Safety Monitoring Boards (DSMB).
Role type
Senior Clinical Safety Specialist (CEC/DSMB Adjudication)
Builds
CEC/DSMB study start-up and close-out activities, including charter development, member contracting, and electronic adjudication system builds.
Domain
Clinical Research / Pharmacovigilance / Medical Safety
Deliverable
client delivery
Required skills
CEC/DSMB study lifecycle management, adjudication system configuration, regulatory compliance, therapeutic area knowledge, dossier compilation, secure data management, project coordination, audit preparation
Preferred skills
Pathophysiology understanding, critical thinking, problem solving, presentation skills, budget and metric review
Technologies
Electronic adjudication systems, Microsoft Office (Outlook, Word, Excel), multiple clinical databases
Responsibilities
Perform day-to-day CEC/DSMB activities independently, review adjudication publications and regulations, prepare and QC CEC dossiers, maintain secure unblinded data files, assist with project implementation and client/investigator meetings, prepare for audits
Seniority
Senior, hands-on IC