Sr Safety Committee Specialist - Adjudication (Night Shift)
- Philippines
- Permanent
- Full-time
- Proficient in CEC/DSMB study start-up activities (charter development, member contracting, electronic adjudication system build) and close-out activities.
- May act as the company's liaison for CEC/DSMB with the sponsor and assist the company's project teams in executing CEC/DSMB strategies
- Works independently to perform day-to-day CEC / DSMB activities through expert knowledge of specialty committee processes and procedures.
- Reviews adjudication/DSMB publications and information sources to keep updated on current regulations, practices, procedures and proposals related to changes in CEC and DSMB practices.
- Maintains medical understanding of applicable therapeutic area and disease states.
- Prepares and QCs CEC dossier compliation and submission.
- Maintains secure files for DSMB unblinded data.
- Assists with routine project implementation and coordination, including presentations at client/investigator meetings, and review of metrics and budget considerations as they relate to specialty committee activities.
- May assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings representing the CEC and/or DSMB speciality specialty committee functions