Pv Ra Mw Coordinator/safety Admin - Tlahuac, México - Thermo Fisher Scientific

Thermo Fisher Scientific
Thermo Fisher Scientific
Empresa verificada
Tlahuac, México

hace 4 semanas

Rodrigo Fernández

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee
Descripción

Summarized Purpose:


Provides contracted project coordination and safety support on global and domestic programs with an emphasis on serious and non-serious adverse events, protocol inquiries, physician assessment of diagnostics, Data and Safety Monitoring Boards and Endpoint Adjudication Committees.

In collaboration with Safety Specialists and Medical Monitors, liaises and establishes effective relationships with internal functional team members to implement projects, prepare contractual documents, coordinate and facilitate meetings and accurately manage all incoming safety documentation.


Essential Functions
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 logístical 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.
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.


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).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

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