About

About Me

I am a detail-oriented and results-driven clinical research professional with a Master’s degree in Pharmaceutics and a strong foundation in pharmaceutical sciences. With extensive hands-on experience in managing Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and Trial Master File (TMF) platforms such as ELVIS and Wingspan, I specialize in ensuring process efficiency, regulatory compliance, and high-quality project execution across global clinical trials. My core responsibilities include maintaining high site compliance through accurate CTMS data entry, overseeing site milestone and subject tracking, and managing audit-ready TMF documentation in accordance with ICH-GCP and SOP standards. I proactively support cross-functional teams by facilitating training compliance, managing study payments, and handling system access management across various platforms. I am technically proficient in Microsoft Excel, VBA Macros, and Power BI—developing automated trackers and interactive dashboards that provide valuable insights into site performance, query trends, and project health. Notable contributions include building the Quality Data Review (QDR) dashboards and automating trackers such as the SRtE and Site Monitoring Visit Trackers, significantly reducing manual workload and enhancing reporting accuracy. In recognition of my subject matter expertise, I have served as an Instructor-Led Training (ILT) Facilitator at IQVIA, onboarding new hires with structured training on tools and systems. As a Subject Matter Expert (SME) in Excel, IWRS, and SRtE, I regularly conduct knowledge-sharing sessions and troubleshooting support to uplift team capabilities. My strengths lie in combining domain expertise with technical skills to drive continuous improvement, enhance operational transparency, and deliver quality outcomes in every project I’m part of.

• Profile: Centralized Monitoring & Project Management
• Domain: Contract Research Org
• Education: Masters in Pharmaceutics
• Language: English, Hindi, Kannada, Bengali
• BI Tools: Microsoft Power BI & Spotfire
• Other Skills: Power BI, Excel,SQL,Python & SEO