Anuja Manjunath Dargopatil

Experience

1. Sr Clinical Data Coordinator

   IQVIA India

   Feb 2023 — Present

   Clinical Data Manager | Clinical Research & Data Management6 years of experience in end-to-end clinical data management across global clinical trialsKey Responsibilities:Managed complete Clinical Data Management (CDM) lifecycle for Phase studies, ensuring high-quality, compliant, and audit-ready clinical data.Designed, developed, and validated eCRFs in platforms such as Medidata Rave / Oracle Inform (customize if needed).Prepared and reviewed CDM documents including Data Management Plans (DMP), CRF Completion Guidelines, Edit Check Specifications, and Data Validation Plans.Performed data cleaning, discrepancy management, and real-time data review to ensure accuracy and protocol compliance.Generated, tracked, and resolved queries by closely collaborating with clinical sites and cross-functional teams.Performed external data reconciliation (SAE, lab data, PK/PD, imaging reports) and ensured integration with EDC.Conducted medical coding oversight using MedDRA and WHO-Drug dictionaries.Supported database testing (UAT), edit check programming, and performed database lock/freeze activities.Collaborated with Biostatistics and Medical Monitoring teams to support listings review and data quality checks.Ensured compliance with GCP, ICH-E6, CDISC/CDASH, and sponsor SOPs throughout

Education

• Clini India

  Post Graduate Diploma ln Clinical Research and management

  2016 — 2016

• Dr.D.Y. Patil Institute Of Pharmacy

  Bachelor's Of Pharmacy

  2012 — 2016

• Solapur University

  HSC

  2010 — 2012