Job Description

Coordinates the timely review of protocol inquiries, serious and non-serious 
adverse events, diagnostics and Data Safety Monitoring Board data; tracks all 
necessary data and generates reports for the client, project team and/or external 
vendors. 
 Represents the organization's DSMB/EAC Coordination Team at global and 
domestic committee meetings (both via teleconference and face-to-face) 
alongside the client, board members, third party vendors and the project team, 
coordinating all logistical aspects and assisting with facilitation. 
 Interfaces with various internal and external parties to implement projects, 
prepares Confidentiality Disclosure Agreements, Letters of Intent and Member 
Agreements based on contractual considerations; reviewing all contractual 
documents for accuracy and coordinating internal and external approvals. 
 Compiles adjudication dossiers and creates/submits follow-up to investigative 
sites. 
 Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded 
and unblinded minutes/materials to client portals and distributes to internal and 
external project teams. 
 Manages project specific training and the set-up, maintenance and archival of 
program files; ensuring PV remains audit ready. 
 Identifies and redacts subject identifiers per local requirements, retrains sites 
and escalates reoccurrences to the organization's Data Privacy. 
 Performs data entry into internal/external datases, tracking systems and the 
organization's budget management system; performs system reconciliations to 
identify issues which may negativley impact project timelines. 
 Oversees expenses and manages translations; ensuring budget parameters are 
not exceeded. 
 Supports any specific activities performed by the local office, which cannot be 
performed from elsewhere. 
 Provides training to junior staff.