Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job 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 company's liaison for CEC/DSMB with the sponsor and assist the company's project teams in executing CEC/DSMB strategiesWorks 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