- Review clinical trials 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. 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.
- Apply quality control procedures and checks to ensure data quality standards (client and Labcorp) are achieved.
- 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, eDiary, specialty laboratory, etc.)
- 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 further investigation.
- Assist in the development and testing of data management system edit / data validation checks and special listings / procedures used as tools for the data review and discrepancy management activities.
- Support the training of project staff on project-specific, global, standardized data management processes.
- Perform other duties as assigned by management.
3 to 5 yrs in CRO or Pharma
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