- 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.
- Apply quality control procedures and checks to ensure data quality standards (client and Covance) 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 (diagnostics) 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.
Master or Bachelor degree
More than 1 year experience on DM.
Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed