Jagannath Roy

About Jagannath Roy

I am a clinical operations professional with a Master’s in Pharmaceutics and hands-on experience supporting global clinical trials across various phases. My expertise spans clinical system support, documentation compliance, site activation, and data analytics in the life sciences domain.I specialize in managing systems such as CTMS, EDC (Rave, Inform), IRT (IWRS/IXRS), eTMF (ELVIS, Wingspan, Veeva Vault), Clario eCOA, Drug Dev, Site Greenlight, and Spotfire — ensuring operational excellence and data integrity throughout the trial lifecycle.Key areas of expertise:Access Management: Handling system access provisioning across study platformsSRtE & Site Activation: Maintaining SRtE trackers, preparing ISF binders, and coordinating site readiness activitiesDocumentation Oversight: Managing TMF/eTMF completeness, QC, and audit readiness as per ICH-GCP and SOPsSite Communication: Coordinating with site teams for action item follow-up and document collectionSite Payment Support: Verifying site payment invoices via Payment Portal by cross-checking CTA terms and EDC subject visit dataData & Reporting: Creating Power BI dashboards, Excel-based trackers, and automation tools using VBA, SQL, and Power QueryRecognized as a Subject Matter Expert (SME) in Excel, SRtE, and eTMF systems, I also contribute to team training and continuous process improvement. I’m passionate about streamlining clinical operations through technology, data insights, and cross-functional collaboration.

Experience

1. Clinical Trial Support Associate

   Sanofi

   Oct 2025 — Present · Hyderabad, IN

Education

• SkilloVilla

  Certificate Program, Data Analytics and Python

• PES University

  M pharm, Pharmaceutics

• Rajiv Gandhi University of Health Sciences

  Bachelor of Pharmacy - BPharm, Pharmacy