Safety Committee Administrator

About the role

Thermo Fisher Scientific is hiring a Safety Committee Administrator to provide moderate contracted project coordination and safety support on global and domestic programs, with an emphasis on Data and Safety Monitoring Boards (DSMB) and Endpoint Adjudication Committees (CEC). The role covers DSMB/CEC set-up, member contracts, payments, meeting arrangements and minutes, and liaison with internal and external parties.

Key responsibilities

• Represent the DSMB/EAC Coordination Team at global and domestic committee meetings (teleconference and face-to-face) and coordinate logistics and facilitation.
• Prepare confidentiality disclosure agreements, letters of intent and member agreements, review contractual documents and coordinate approvals.
• Compile, create and submit follow-up to investigative sites; coordinate meetings, draft minutes and post them to client portals.
• Manage project training and program files so that PV remains audit-ready, and redact subject identifiers per local requirements.
• Enter data into databases, reconcile systems and oversee expenses such as committee, travel and translation costs.
• Support the Safety Committee Specialist with dossier building, distribution and filing, and liaise with internal functional teams.

Required profile

• High or secondary school diploma or equivalent, with relevant formal academic or vocational qualification; technical positions may require a certificate.
• Previous experience providing the knowledge, skills and abilities to perform the job (at least 2 years comparable).
• Working knowledge of FDA regulations, ICH GCP and the company's/clients' SOPs and WPDs for non-clinical and clinical aspects.

Required skills

• Excellent computer skills, including MS Office (Word, Excel, PowerPoint, Access)
• Strong problem-solving, attention to detail and ability to work independently with minimal supervision
• Ability to analyse project data, prioritise tasks under tight deadlines and communicate diplomatically with clients and project teams