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 supp01i the review of clinical trial data.
+ Generate, resolve and track queries to address problematic data identified dming data review activities and apply proper modification I col'!'ection to the database.
+ Interact with the dictionary coding and maintenance group to ensure appropriate process set-up
+ Perform reconciliation of the clinical and safety databases.
+ Perform reconciliation of central laboratory and I or third party vendor data (eCRF, edDiary, specialty laboratory, etc.).
+ Perform aggregate review of clinical data by patient, site and I or project to identify data trends (patient safety, compliance, etc.) and I or data inconsistencies that require further investigation.
+ Apply quality control procedures and checks to ensure data quality standards (client and
Covance) are achieved.
+ Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), monitoring conventions, CRF (eCRF) completion guidelines, etc.
+ Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
+ Assist in the development of the clinical data model and/or database design and annotate the
CRF (eCRF) according to these specifications.
+ Assist in the creation of data acquisition conventions and data review guideli nes I diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCFR) completion I monitoring conventions.
+ Assist in the development and testing of data management system edit I data validation checks
(diagnostics) and special listings I procedures used as tools for the data review and discrepancy management activities.
+ Potentially interact and collaborate with other project and specialty team members (clinical, programmi ng, statistics, CDM technical support, drug safety, etc.) to suppmt the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality,
+ Potentially serve as client contact for project meetings and CDM status updates.
+ Suppmt the training of project staff on project-specific, global, standardized data management processes.
+ Peiform other duties as assigned by management.