Ankit Koura

Move EDC data into CTMS and ensuring data is being integrated. Gather required documents, which includes but not limited to EDC study configuration, metadata files, study budget and site list information. Request and review budget contracts and compare the EDC visit structure and site budget. Map visits in iGPS to ensure the payment of assigned studies which could include study set-up, maintenance, timely and accurate payment to the sites, as well as issue resolution and study reconciliation.

Develop and Update eCRF Screens as per Study Design specification in Central Designer application. Create new study specific checks and Implement standard library checks as per Edit Check specification. Conduct version control process (eCRF Screen changes, study specific rules updated/creation changes) to production InForm studies. Perform mapping of data models in DMW and make changes to the target model of an existing transformation and upgrade the transformation to reflect the changes in final model.

Create Validation Checks in DMW application to run across EDC and lab data; to standardize data structures for review, cleaning, and analysis; and to pass discrepancy review among teams. Create PL/SQL stored procedures, functions and packages for moving the data from staging area to data mart in LHS (Oracle Life Sciences Data Hub). To Develop and Update eCRF Screens as per specifications. Perform eCRF Screen changes, study specific rules updated/creation as per the DVS updates and Unit Testing as requested.

Worked in several phase I-IV trials and has strong understanding of Drug development Processes. (Like Life Science GxP and 21 CFR part 11) Create Rules (edit check) development in Central designer as per EDS (edit check specification) document provided by Design consultant and deploy the latest package to InForm. Develop electronic clinical data management (eCDM) systems (eCRFs, edit checks, visit structures, system settings, role assignments, etc.) and Doing Scoping of the Customer Requirement.