Hemanth Kumar
Senior Clinical Data Specialist at Covance
- Role
- Senior Clinical Data Specialist at Covance
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Hemanth Kumar
Working as a Principal Clinical Data Scientist in Novartis India, having more than 12…
Experience
Senior Clinical Data Specialist
Feb 2018 — Present · Bengaluru, IN
Review clinical trials data in accordance with [Global] Data Management Plans and applicable standardized data management processes (Sops, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data and run ancillary programs (e.g. special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.• Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database.• Perform reconciliation of the clinical and safety databases, reconciliation of central laboratory and/or third party vendor data (eCRF, eDiary, specialty laboratory, etc.) and perform aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation.Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), monitoring conventions, CRF (eCRF) completion guidelines, etc.• Assist in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications, in the creation of data acquisition conventions and data review guidelines / edit check specifications consistent with the clinical data model,[statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions, and in the development and testing of data management system edit / data validation checks and special listings / procedures used as tools for the data review and discrepancy management activities.• Potentially interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
Education
Rajiv Gandhi University of Health Sciences
Bachelor’s Degree
2007 — 2011
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