Pruthvik G

About Pruthvik G

As a dedicated Clinical Data Management Associate at Accenture, I bring over two years of specialized experience in clinical trials data management, IRT system validation, and QA & QC analysis. My role involves ensuring the accuracy and integrity of clinical trial data through rigorous testing and validation processes. I am constantly seeking new challenges and opportunities to leverage my skills in a dynamic and impactful environment. Let\'s connect if you are looking for a detail-oriented professional with a strong background in clinical data management and system validation.

Experience

1. Sr Clinical Data Management Associate

   Accenture

   Sep 2024 — Present

   A process of Validating and documenting that the specified requirements of a IRT system, consistently fulfilled from design until decommissioning of the system or transition to a newsystem. The approach to validation (User Acceptance Testing) is be based on a risk assessment that takes into considerationthe intended use of the system and the potential of the system to affect human subject protection andreliability of clinical trial results.•Provides Support for execution of IRT/IXRS systems User Acceptance Testing, development process from UAT planning, to system go-live, ongoing system change control.•Develops UAT plans, Trace Matrix, Risk Assessments, Gap Analysis, Test Scripts, Data set-up requests and Test summary reports.•Reviews and provides approval of required IRT trial-specific documentation.•Execute UAT test scripts.•Address UAT findings with Vendor and Core team.•Ensure appropriate UAT documentation is generated.•Perform Quality Control reviews and approvals of the validation strategy and deliverables to sustain compliance.•Perform data security activity, Reconciliation and essential document review as required.

Education

• NMAM Institute of Technology

  Bachelor of Engineering - BE, Biotechnology

  2017 — 2021