Responsibilities
- Oversee all data management tasks in large, complex studies with general oversight, or independently manage data activities in smaller to mid-sized trials
- Serve as the main contact for internal teams and departments on matters related to clinical data management
- Act as the key point of contact for clients and vendors regarding data management components and reporting for clinical studies
- Coordinate data management tasks across clinical projects, including EDC system development, data capture, cleaning, reconciliation, database lock, final database integration, and delivery of data management outputs
- Lead clinical data management efforts within study teams, including review of study-related documentation
- Develop and review data management plans and other project-specific protocols and instructions
- Organize and conduct user acceptance testing for data systems and tools
- Create data validation plans and specifications for edit checks
- Manage and supervise data entry operations, providing feedback on data quality and resolving entry issues
- Perform data validation through automated and manual reviews, resolve data discrepancies, generate and close queries, and report data quality to study teams
- Handle non-CRF electronic data, including receipt, archiving, loading into databases, resolving reconciliation issues, and providing quality feedback to external providers
- Manage database edits for paper-based CRF studies
- Conduct manual review of CRFs focusing on non-medical data accuracy
- Lead the process to finalize and lock clinical databases
- Coordinate and supervise the handling, distribution, and archiving of CRFs and query forms
- Contribute to the design of CRFs and other data collection instruments, ensuring alignment with study protocols and accuracy
- Develop guidelines for proper CRF completion
- Code medical data using standardized dictionaries and review coding outputs (requires medical or biology background and additional training)
- Perform reconciliation of serious adverse events (SAEs)
- Review and approve specifications for electronic data transfers, including imports and exports
- Collaborate with the Document Center to ensure proper maintenance of TMF and eTMF records
- Conduct and document quality control checks on clinical databases
- Assist in preparing for and attending internal, client, or third-party audits and inspections related to data management
- Support follow-up actions and resolution of findings identified during audits related to data management processes
- Provide training and guidance to Assistant Data Managers
