MAJOR RESPONSIBILITIES: Supervise and/or oversee all study-related procedures to ensure they are carried out in accordance with protocol and regulatory guidelines. Provide status updates regarding projects to clients and other departments. Review draft protocol and coordinate operations in order to meet protocol requirements. Manage pre-defined study timelines and be proactive in identifying delays and possible solutions to meet deadlines. Collaborate with other departments to create study specific procedures and forms as per guidelines. Approve initiator configuration. Provide appropriately QC'd study raw data to Medical Writing team for report completion. Perform quality control of clinical reports by utilizing protocol and procedural deviations reports, sample inventory, and medical writers. Participate in the revision of SOPs.
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