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Responsibilities/Duties
? 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.
*Education/Qualifications
Bachelor and above/医药相关教育背景