aiswarya thomas

Managed data management activities for clinical trials, ensuring compliance with SOPs and GCP.

Performed all data management tasks in compliance with SOPs and GCP gas appropriate to include, but not limited to query management, page reviews, listing reviews such as medical history, adverse events, concomitant medication and SAE reconciliation. Lead data management team for Phase I and Phase III clinical trials on HIV. Managed external vendor data collection and quality assurance processes a

Specialized in external vendor data management and reconciliation of raw electronic data against EDC databases. Managed reconciliation of laboratory data, vendor reports, and external data sources for accuracy and completeness. Ensured external data transformation met quality standards per Data Transfer Agreement, Data Transfer Specification and Data Management Plan. Freezing-Locking and quality c

Assisted in clinical data analysis and management activities.

Assisted in maintainance of Xcellerate Edit Checks for Discrepancy status management for check of Vendor data. Conducted user acceptance testing (UAT) for EDC systems and data collection modules across multiple studies. Experience in performing SAS checks UAT for Third Party Vendor Data to assess if the data transfer meets DTS requirement. Perform Database UAT/ eCRF UAT according to applicable Val

Completed clinical pharmacy internship at Government Medical College Kannur.

Grade: 72%

Grade: 71%

Pursuing a Master of Research in Public Health at the University of Wolverhampton.

Grade: 72%

Completed MRes Public Health with a grade of 72%.

Grade: 71%

Completed Doctor of Pharmacy (PharmD) with a grade of 71%.

Grade: 71%

Completed Doctor of Pharmacy (PharmD) with a grade of 71%.