Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management processes (SOPs; Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.
Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
- Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database.Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application.
- Assist with the reconciliation of central laboratory and / or third party vendor data (eCRF, edDiary, specialty laboratory, etc.).
- Apply quality control procedures and checks to ensure data quality standards (client and Labcorp) are achieved.
- Assist with the aggregate review of clinical data by patient, site and/ or project to identify data trends (patient safety, compliance, etc.) and / or data inconsistencies that require fulther investigation.Suppolt the training of project staff on project-specific, global, standardized data management processes.
- Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
- Perform other duties as assigned by management.
2-6 years of relevant Clinical Data Management experience
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