Safety Committee Specialist – Adjudication

About the role

The Safety Committee Specialist supports Clinical Endpoint Committees (CEC) and Data Safety Monitoring Boards (DSMB) in a highly regulated environment. The role involves managing day‑to‑day committee activities, collaborating with cross‑functional teams, and ensuring compliance with current regulations and procedures.

Key responsibilities

• Initiate CEC/DSMB study start‑up activities, including charter development, member contracting, and electronic adjudication system build.
• Complete CEC/DSMB close‑out activities and maintain secure files for unblinded data.
• Perform daily CEC/DSMB operations using expert knowledge of committee processes and procedures.
• Review adjudication and DSMB publications to stay updated on regulations, practices, and procedural changes.
• Maintain medical understanding of relevant therapeutic areas and disease states.
• Prepare and quality‑check CEC dossier compilation and submission.
• Assist with project implementation, presentations at client/investigator meetings, and budget‑related considerations.
• Support the preparation of departmental procedures, attend audits, kick‑off meetings, and represent CEC/DSMB functions.

Required profile

• Bachelor’s degree or equivalent with relevant academic or vocational qualification.
• Previous experience that provides knowledge of clinical safety committee processes, regulatory environments, and stakeholder collaboration.

Required skills