Safety Committee Administrator
Core
Coordinate and administer Data and Safety Monitoring Boards (DSMB) and Endpoint Adjudication Committees (CEC) for global clinical research programs.
Role type
Project coordination administrator for clinical safety committees
Builds
Contracted DSMB/CEC services for pharmaceutical and biotech clients
Domain
Clinical research / Clinical trials
Deliverable
client delivery
Required skills
Contract management, meeting logistics, dossier preparation, data entry, expense management, regulatory compliance (FDA/ICH), document redaction
Preferred skills
Experience with Event Adjudication Systems, knowledge of clinical trial SOPs
Technologies
Event Adjudication System, MS Office (Word, Excel, PowerPoint, Access), internal/external databases, tracking systems
Responsibilities
Perform DSMB/CEC set-up and member contract execution; arrange meeting facilities and draft minutes; compile and submit follow-ups to investigative sites; manage project files and training; identify and redact subject identifiers; perform data entry and system reconciliations; oversee expenses for committee members.
