- Review and manage DM activities in vendor proposals, budgets, and scopes of work.
- Review and provide input into clinical study documents including protocols, SAP, and CSRs.
- Oversee all data management activities performed by CROs as the internal DM Study lead.
- Review and manage key documents including data management plans, CRF completion guidelines, and SAE reconciliation.
- Oversee eCRF design, database design specifications, and UAT of the clinical database.
- Lead internal study teams in data review and quality issue identification.
- Define and oversee data transfer specifications for external data sources and lab reconciliation.
- Collaborate on implementing electronic systems, data aggregation tools, and emerging EDC technology.
Project Management