• Job Description

  Req#: R-01319097

  Work Schedule

  Standard (Mon-Fri)

  Environmental Conditions

  Office

  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

• About the company

  Thermo Fisher Scientific is an American provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.

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