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Manjusha Kondepudi

@manjushakondepudi

Clinical Research Associate at IQVIA monitoring Phase II–III oncology trials across 9 investigative sites and 4 protocols.

United States

Message

At IQVIA, I monitor Phase II–III oncology trials across 9 investigative sites and 4 protocols. I conduct source data verification and review, resolve queries, and author monitoring visit reports.

At SUNY UPSTATE MEDICAL UNIVERSITY, I supported 15+ concurrent oncology protocols and 130+ enrolled patients. For SWOG S2206, I managed investigational device accountability, protocol compliance, IRB documentation, and clinical data.

At OCUFLOW, I contributed to 510(k) and pre-submission documentation for a Class II ophthalmic diagnostic device. My MS in Regulatory Affairs and BDS support my work in clinical research and regulatory compliance.

Experience

Work history, roles, and key accomplishments

Current

Clinical Research Associate I

Current

IQVIA

Nov 2025 - Present (10 months)

Monitor Phase II–III oncology trials across 9 investigative sites and 4 protocols, conducting on-site and remote monitoring visits in accordance with ICH-GCP. Perform SDV/SDR, author monitoring visit reports, and drive site compliance.

SDV SDR Medidata EDC Veeva Vault CTMS ICH GCP Oncology Phase II III Trials Site Monitoring Query Resolution Data Reconciliation Protocol Deviations Essential Document Collection IRB Investigational Product Accountability Monitoring Visits

Clinical Research Associate

SUNY Upstate Medical University

Oct 2023 - Nov 2025 (2 years 1 month)

Site-based CRA role at an NCI-affiliated academic medical center, managing regulatory, documentation, and clinical data across 15+ concurrent oncology protocols and 130+ enrolled patients. Managed investigational device accountability and essential document control.

Medidata EDC Essential Document Collection ISF IRB Protocol Amendments Continuing Review Informed Consent Forms SAE Reporting ICH GCP Regulatory Compliance Document Review CRFs Review Query Resolution Protocol Deviations Oncology Phase II III Trials Investigational Product Accountability

Regulatory Affairs Intern

Ocuflow

Apr 2023 - Jul 2023 (3 months)

Contributed to 510(k) and pre-submission documentation packages for a Class II ophthalmic diagnostic device. Reviewed technical documentation and compliance records with cross-functional teams to ensure submission-ready accuracy.

510(K)Pre Submission Meetings FDA Regulatory Affairs Medical Devices Ophthalmic Diagnostics Design History File (DHF)QA R&D

Clinical Research Coordinator

KIMS Hospitals

Sep 2019 - Nov 2020 (1 year 2 months)

Coordinated an observational study on Oral Submucous Fibrosis and a comparative interventional study evaluating steroid-based treatment protocols. Documented and reported adverse events and performed clinical data review and reconciliation.