Viswanath Reddy

About Viswanath Reddy

Tmf Analyst professional having 6 of years’ experience with strong knowledge on maintenance and QC of e-TMF documents generated during clinical trials. Gained knowledge of drug development process and experience as Clinical Research Coordinator at Investigator site. •Drive completeness and quality of TMF content for all assigned clinical trials until study close out. Manage TMF activities in accordance with the contracted budget for TMF Operations. •Lead the development and implementation of the TMF specifications, such as process and system changes. •Primary point of contact for internal and external audits of study TMF-related queries and support the preparation of appropriate audit and inspection responses. •Effectively monitor and report on progress of the TMF to all stakeholders.

Experience

1. Tmf Specialist

   IQVIA

   Jul 2019 — Present · Bengaluru, IN

   Perform eTMF periodic Review of documents for Content & Completeness check• Perform eTMF Reconciliation tasks (Missing document, duplicates identification etc)• Follow with action owners for Open TMF Issues• Maintain the eTMF in state of Inspection Readiness• Ensure eTMF is always audit ready• Review and respond to TMF content quality issues and identifies trends per study and across programs; alerts management of trends• Compliance to TMF Completeness, TMF Reviews & TMF Issue Resolutions• Commitment to continuous improvement of TMF delivery• Driving a culture of Inspection Readiness• Creating a seamless TMF delivery process.

Education

• Sv degree college

  Master of Science

  2014 — 2016