Sindhu G

About Sindhu G

Clinical research expertise in managing Phase studies, including Trial Support and…

Experience

1. Clinical Trial Associate

   AstraZeneca

   Mar 2023 — Present

   Therapeutic Focus: Oncology – Lung Cancer, Breast Cancer, Gastric Cancer, NSCLC*Manage the setup, maintenance, and reconciliation of Trial Master File (TMF) and Investigator Site File (ISF) using Veeva Vault, ensuring documentation is inspection-ready and compliant with ICH-GCP and FDA regulations.*Support oncology clinical trials by maintaining accurate and up-to-date regulatory documentation across various phases of studies, with a strong focus on data integrity and audit readiness.*Coordinate regulatory submissions to IRBs/IECs and maintain communication with central IRBs like WCG for efficient document flow and compliance with submission standards.*Facilitate and manage vendor system access for site staff and clinical teams, including platforms such as RAVE, CLINPHONE, Signant IRT, Perceptive, HGX Cell Carta, LabCorp, Ventana, Haematogenix, and Clario.*Perform detailed quality control (QC) checks on clinical documentation to ensure version control, accuracy, and alignment with approved templates and SOPs.*Oversee legacy data migration from paper-based systems to eTMF, ensuring accurate data reconciliation and maintenance during system transitions.*Utilize Power BI and Excel to analyze clinical trial metrics, reconcile data entries, and support reporting activities for ongoing study oversight and compliance tracking.*Act as a central communication point for internal teams, vendors, and site personnel, assisting with coordination, document archiving, and the preparation of study trackers, reports, and presentations using SharePoint, MS Word, and PowerPoint.

Education

• Sacred Heart University

  Master’s in Helathcare Informatics, Health Care Informatics