poornima swamy

• Assisted with database upgrades and migrations by performing user acceptance testing.
• Create and update completion guidelines, DMP, Data Validation Plan (DVP) .
• Ensure electronic vendor data contains all protocol specific parameters, is in Correct format and data populate to the specified fields and patients correctly.
• · Perform clinical database development, including data entry screen design, testing and validation.
• To make sure reference ranges are completely updated for all the local lab pages (LNR entry) and any discrepancies reported to Labs.
• · Perform eCRF review, query management and locking of pages.
• Perform initial coding of verbatim entries on adverse events, medical history, and medications according to MedDRA and WHO Drug dictionaries.
• Database expertise on RAVE, IBM, OPVERDI and VIEDOC .

• Assisted with database upgrades and migrations by performing user acceptance testing.
• Have worked on 100% DB UAT in Rave environment of all the edit checks related to lab eCRF.
• Create and update Data Transfer Agreement and Data transfer specifications for vendor data transfers and Lab addendum.
• Liaised with external vendors for seamless integration of third-party applications into existing workflows.
• Responsible for performing Monthly (or as applicable) reconciliation of lab data and highlighting the discrepancies to the vendor via issue log/site or CRA via queries in EDC.
• Responsible for drafting local lab and central lab edit checks and involved in performing UAT of the checks in SAS and document it until moved to production.
• Perform eCRF review, query management and locking of pages and documentation.
• Database expertise on Rave and INFORM platform.

Handled science for students.

Have been involved in customer support and interactions with vendors and have experience on using SAS tool.