Safety Committee Specialist – Adjudication
Thermo Fisher Scientific · Mexique
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
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