- Serve as day-to-day operational point of contact for CROs and vendors, tracking deliverables and flagging risks.
- Review study documents for quality, including monitoring reports, protocol deviations, and TMF entries.
- Coordinate study startup activities such as site activation, regulatory document collection, and vendor kick-offs.
- Manage study trackers, timelines, and action logs to provide visibility for cross-functional teams.
- Support safety reporting coordination and ensure timely distribution of SAE/SUSAR notifications.
- Monitor TMF completeness and assist in inspection readiness activities.
- Review CRO-managed study metrics, site performance, and data cleaning progress.
- Support vendor invoice review and budget tracking against contracted activities.