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Safety Committee Specialist – Adjudication

Thermo Fisher Scientific · Mexique

Nuevo
🇬🇧 English

Descripcion del puesto

About the role

Thermo Fisher Scientific is seeking a Safety Committee Specialist to support Clinical Endpoint Committees (CEC) and Data Safety Monitoring Boards (DSMB) in a highly regulated environment. You will manage day‑to‑day committee activities, ensure compliance with regulatory standards, and collaborate with cross‑functional teams to drive high‑quality adjudication processes.

Key responsibilities

  • Initiate CEC/DSMB study start‑up activities, including charter development, member contracting, and electronic adjudication system configuration.
  • Execute day‑to‑day CEC/DSMB operations, maintaining accurate records and secure files for unblinded data.
  • Prepare, QC, and submit CEC dossiers, and support study close‑out activities.
  • Stay current on regulations, practices, and therapeutic area knowledge through review of publications and industry updates.
  • Assist with project implementation, presentations at client/investigator meetings, and budget considerations related to committee activities.
  • Contribute to departmental procedures, audit preparation, and represent the committee functions at kick‑off and investigator meetings.

Required profile

  • Bachelor’s degree or equivalent with relevant academic or vocational qualification.
  • Prior experience in clinical trial safety committees, adjudication processes, or related regulatory environments.
  • Strong understanding of therapeutic areas and disease states relevant to clinical research.

Required skills

  • Proficiency with electronic adjudication platforms and related software systems.
  • Experience managing secure data files and documentation for CEC/DSMB activities.

What we offer

  • Opportunity to work with leading pharmaceutical and biotech companies on global clinical trials.
  • Access to resources that support professional growth and career development.
  • Collaborative environment focused on improving health outcomes worldwide.

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Thermo Fisher Scientific

Mexique