1. Review and understand the Study Protocol, DVP, Edit Check Specification, eCRF.2. Prepare and review study documentation like Data Entry Guidelines and CRF Completion Guidelines etc.3. Perform data entry, verification and Identification of data issues during entry.4. Perform assigned data validation activities.5. Perform external checks, to handle manual discrepancies and action the same. 6. Generate queries to clarify and improve the quality of the data.7. Review of… Show more 1. Review and understand the Study Protocol, DVP, Edit Check Specification, eCRF.2. Prepare and review study documentation like Data Entry Guidelines and CRF Completion Guidelines etc.3. Perform data entry, verification and Identification of data issues during entry.4. Perform assigned data validation activities.5. Perform external checks, to handle manual discrepancies and action the same. 6. Generate queries to clarify and improve the quality of the data.7. Review of query language used in Data Clarification Form. 8. Review the resolved discrepancies and close where appropriate. 9. To ensure an error free, quality data with no open queries. 10. Perform Database audit as part of QC. 11. Ensure that all discrepancies identified and all resolutions are updated by Validation Team appropriately and per timeline set.12. Regular attending meetings with Senior CDC and ADM 13. Regular meetings with team members so as to be updated with regards to studies status. 14. Maintain all the study related documents like DCF tracker, Query Status tracker, Entry Verification sheet etc. Show less

Data Entry Data VerificationQuality Checks

Case Report Form Design with Adobe Page makerEDCDatabase DesignUser Acceptance Testing (DATABASE QC)Edit Check SpecificationEdit Check Testing Query DefinitionDescripency ManagementData ValidationDatabase ClosureSAE ReconciliationQC & QA