Sr Safety Committee Specialist - Adjudication (Night Shift)
Sr Safety Committee Specialist - Adjudication (Night Shift)
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Performs experienced day-to-day committee activities for Clinical Endpoint Committees (CEC) and/or Data Safety Monitoring Boards (DSMB) within a highly regulated environment. Displays an experienced knowledge of the procedures and electronic platforms/ software systems utilized for direct communications with the CEC and/or DSMB commitees 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:
- Proficient in CEC/DSMB study start-up activities (charter development member contracting electronic adjudication system build) and close-out activities.
- May act as the companys liaison for CEC/DSMB with the sponsor and assist the companys 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
Required Experience:
Senior IC
Employment Type
Full-Time
