Coordinates the timely review of serious and non-serious adverse events; tracks all necessary data and generates reports for the client, project team and/or external vendors.
Represents the organization's Literature Team at literature-related meetings (both via teleconference and face-to-face) alongside the client, 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; reviewing all contractual documents for accuracy and coordinating internal and external approvals.
Coordinates/facilitates project meetings, drafts meeting minutes, posts 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 staff and escalates reoccurrences to the organization's Data Privacy.
Performs data entry into internal/external databases, tracking systems and the organization's budget management system; performs system reconciliations to identify issues which may negatively impact project timelines.
Oversees expenses and manages translations and literature article procurement; ensuring budget parameters are not exceeded.
Coordinates department functions and performs other duties as assigned.
Supports any specific activities performed by the local office, which cannot be performed from elsewhere.
