Govardhana R
Clinical Data Specialist @Svasth Life
Signup · Get unlimited contacts
WORK HISTORY
Clinical Data Specialist @Svasth Life
Bengaluru, IN
Review the Data Management Plan (DMP) and provide input to the client as needed. Participate in Data Quality and Safety Team (DQST) meetings to provide updates on the study\'s status, identify risks, and propose risk mitigation plans. • Test and review data listings, coordinating with the Data Team Lead (DTL) or Data Management Lead (DML) if necessary. Based on listing reviews, raise and resolve queries in the Electronic Data Capture (EDC) system. Escalate unresolved issues in the issue log for resolution with the client. • Ensure project quality by identifying quality risks and issues, addressing concerns raised by the project team, and implementing appropriate corrective and preventive actions. • Support the reconciliation of Serious Adverse Events (SAEs) and resolve discrepancies between safety and clinical databases. Review and address queries from the clinical team, and perform User Acceptance Testing (UAT) on newly identified or added listings during migration. • Perform various Clinical Data Management activities, including discrepancy management, offline listing reviews, vendor reconciliations, data validation, query generation, and review of electronic data. • Follow up on studies with onshore study teams, focusing on delivering quality and efficiency. Take responsibility for specific tasks on projects or act as the main contact for Clinical Data Acquisition (CDA) on individual projects. Conduct basic data review. • Analyze data in graphical formats to gain insights and monitor data quality, patient safety, and study risks using analytic and visualization tools. Monitor site performance, and data trends, and escalate issues for sites not meeting expectations using data visualization tools. • Write data clarifications for further assistance from Lead Data Managers, resolve clarifications as directed, and escalate problems to Lead Data Managers or Group Managers. Comply with applicable Data Management sections and standards.
EDUCATION
Rajiv Gandhi University of Health Sciences
Master's degree, M.sc MLT Microbiology and Immunology
NTR University of Health Sciences
Bachelor's degree, B.sc Medical Laboratory Technology
Board of Intermediate Education A.P
Medical Laboratory Technology (Government Vocational Jr.College Anantapur ), Clinical Laboratory Science/Medical Technology/Technologist
ABOUT GOVARDHANA R
Experienced Clinical Data Specialist with a passion for ensuring the integrity and normalization of hospital clinical data. My expertise lies in creating and maintaining clinical terminology content, employing a combination of clinical knowledge and technical skills to map facility system codes to standardized vocabularies. I possess a deep understanding of drug discovery and development, clinical research, and the intricacies of clinical trials. Compliance with regulations such as 21 CFR Part 11 and adherence to ICH guidelines are second nature to me. I am well-versed in the regulatory landscape and maintain an up-to-date knowledge of the ever-evolving requirements. Seeking new challenges in clinical data management, I am driven to leverage my expertise in standardizing clinical terminologies and enhancing data integrity to support improved patient care and facilitate meaningful research and analysis. Let\'s connect to explore opportunities and collaborate on driving forward the accurate exchange and interpretation of clinical information. Let\'s connect and explore opportunities to collaborate on driving forward the accurate exchange and interpretation of clinical information. Together, we can leverage my expertise to support improved patient outcomes, advance healthcare research, and make a lasting impact in the field of clinical data management.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.