Vaishnavi P

Clinical Trial Associate @AstraZeneca

Wilmington, DE, US

Acted as the local study team TMF owner, ensuring ongoing quality, compliance, and inspection readiness of the Trial Master File (eTMF) throughout the study lifecycle-Managed site communications and supported portal activities, facilitating seamless collaboration and document flow across internal and external stakeholders- Generated and analyzed operational reports across multiple clinical systems to support data-driven decision-making and timely issue resolution- Oversaw vendor management activities, coordinating deliverables and tracking performance to ensure alignment with study timelines and expectations-Processed and fulfilled Clinical Trial Management System (CTMS) update requests, maintaining data integrity and accuracy across platforms- Took operational responsibility for the setup, tracking, maintenance, and closure of the local eTMF, ensuring adherence to ICH-GCP and country-specific requirements-Supported CRAs with Investigator Site File (ISF) maintenance and close-out, contributing to audit readiness at the site level- Assisted in the creation and upkeep of study documentation, ensuring consistency with approved templates and compliance with version control standards-Contributed to clinical-regulatory submissions by preparing submission-ready documents per regulatory standards, enabling efficient publishing and regulatory delivery for local (non-global) studies.

H.K.E.S S. Nijanlingappa institute of dental sciences and research

Bachelor's degree

Sacred Heart University

Master's degree