Work Schedule

Environmental Conditions

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. 
 Answers incoming hotline calls, coordinates department functions and performs other duties as assigned. 
 Supports any specific activities performed by the local office, which cannot be 
performed from elsewhere. 
 Provides training to junior staff.

Qualifications: 
Education and Experience: 
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification 
Technical positions may require a certificate 
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).

Working Conditions and Environment: 
 Work is performed in an office environment with exposure to electrical office equipment 
 Potential drives to site locations and/or travel required on rare occasion 
 Majority of work computer-based 
 Long varied hours required on occasion