Keerthi Reddy
Senior Clinical Data Manager | Phase I–IV trials | eCRF Design, UAT Execution, Data Quality, ICH-GCP Compliance | Oncology, Rare Diseases, Cardiology, Respiratory, Neurology, and Infectious Diseases.
- Role
- Senior Clinical Data Manager at Clinvira Inc
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Keerthi Reddy
With extensive experience in Clinical Data Management and experience in managing…
Experience
Senior Clinical Data Manager
Nov 2021 — Present
Managed the complete data management lifecycle for multiple Phase clinical trials in oncology, rare diseases, neurology, and infectious diseases. Designed and reviewed eCRFs in Medidata Rave and Oracle InForm, aligning with CDASH and CDISC standards to ensure accurate and efficient data collection. Led UAT activities by preparing test scripts, documenting findings, and confirming database readiness before study initiation.Oversaw reconciliation of EDC, ePRO, central lab, and imaging datasets, identifying and resolving discrepancies to maintain real-time data integrity. Developed and maintained essential documentation, including Data Management Plans, Data Review Plans, Edit Check Specifications, and Data Transfer Agreements, ensuring regulatory compliance and audit readiness.Worked closely with vendors and cross-functional study teams to coordinate timelines, track deliverables, and ensure budget adherence. Supported interim analyses, freeze cycles, and database lock activities, and maintained TMF/eTMF in an inspection-ready state at all times.
Education
University of Houston-Clear Lake
Master’s in Biotechnology
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.