Thermo Fisher Scientific Looking for Safety Admin at Remote Full Time

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.