Demonstrated experience with Medidata Rave (EDC Build).
Demonstrated experience with eCRF Design.
Demonstrated experience with Edit Checks & Custom Functions.
Demonstrated experience with Migration & Publish Checks.
Demonstrated experience with Targeted SDV (tSDV).
Professional profile
Design and build eCRFs and edit check specifications in Medidata Rave for multi-region clinical studies. Conduct Change Impact Analysis for database amendments across live, global trials. Develop custom functions supporting complex, protocol-driven validation logic. Configure targeted SDV, mail alerts, and RSG mapping, integrating IRT and SAE-to-DES reporting. Manage end-to-end database migration activities, ensuring data integrity across versions and platforms. Perform coding dictionary mapping to support standardized global reporting. Lead multiple studies as primary point of contact, ensuring timely execution and successful release of deliverables
Contributed to the development and maintenance of clinical databases using Medidata Rave, ensuring accurate eCRF design. Developed and validated edit checks, custom functions, dynamics, tSDV, and coding dictionary mapping to enhance data quality. Configured and monitored mail alerts for timely communication of critical data changes. Played a key role in RSG programming and mapping, integrating IRT and SAE-to-DES reporting
Involved in Rave eCRF designing, edit check development, and custom function development. Extensively involved in testing of Rave edit checks, dynamics, derivations, and migration testing