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Safety Committee Specialist - Adjudication
Pharmaceutical Product Development (PPD)
Taguig City, Philippines
Job Description
Performs moderate day-to-day committee activities for Clinical Endpoint Committees (CEC) and/or Data Safety Monitoring Boards (DSMB) within a highly regulated environment. Displays a working knowledge of the procedures and electronic platforms/ software systems utilized for direct communications with the CEC and/or DSMB committees and other external and pre-existing software systems. Effectively collaborates with various parties such as: project team members, data management, biostatistics, client contacts, investigators, committee members, and third party vendors.
A day in the Life:- Initiates CEC/DSMB study start-up activities (charter development, member contracting, electronic adjudication system build).
- Completes CEC/DSMB close-out activities.
- Performs 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.
- Maintain medical understanding of applicable therapeutic area and disease states.
- Prepares and QCs CEC dossier compilation 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 committee functions.
Job posted: 2024-03-08