Vijetha Thokala
Senior Manager, Clinical Data Management
- Role
- Data Quality Lead Lead Clinical Data Manager at Genentech
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Vijetha Thokala
With over 9 years of experience in clinical data management, I am currently the Data Quality Lead at Genentech, a leading biotechnology company that discovers, develops, and delivers innovative medicines for people with serious diseases. In this role, I oversee the planning, analysis, and execution of the data quality objectives for some of the Non-traditional studies (Non-interventional Studies and Decentralized studies) of clinical trials, ensuring compliance with regulatory standards and best practices.I have a Master of Public Administration- health services from Columbus State University and a bachelor\'s degree in health services/Allied Health/Health Sciences. I am proficient in data management activities during study start-up like Protocol Review, eCRF development and review, Edit checks/Data Validation Specifications (DVS), performing User Acceptance Testing (UAT) before Go-Live. Expertise in study conduct activities like Data Review, External Vendor oversight, establishing Data Transfer Agreements (DTA), discrepancy management, external data reconciliations (Lab, SAE, IRT, Imaging, Biomarkers, ePRO, eCOA, Gene related data etc.), interim analysis reports/data cuts and database audits. I am passionate about delivering high-quality data that supports the development of innovative and life-changing treatments for patients.
Experience
Data Quality Lead Lead Clinical Data Manager
Nov 2023 — Present · US
Worked on as Primary point of contact for 3 studies (2 of them are Non-Interventional and Decentralized trials) among OMNI (Ophthalmology, metabolism, Neurology and Immune-oncology) within USMA (US Medical Affairs) group
Education
NTR University of Health Sciences
Bachelor's degree, Health Services/Allied Health/Health Sciences, General
2009 — 2013
Columbus State University
Master of Public Administration- health services
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