Mumbai, Maharashtra, India
Currently working as a Clinical Data Management professional with expertise in CRF design, data validation, query management, edit checks, and preparation of Data Management Plans (DMP). Skilled in EDC systems such as Castor and iMednet, with working knowledge of regulatory guidelines including CDISC standards (SDTM, ADaM), 21 CFR Part 11, and ICH-GCP compliance. Previously worked as a Clinical Research Coordinator with 2 years of experience managing site activities in Pulmonary, Orthopedics, and Cardiovascular studies. Experienced in patient recruitment, informed consent, monitoring support, trial documentation, and ensuring adherence to clinical trial protocols. Hands-on with EDC systems for data entry. Actively looking new opportunities to grow in Clinical Data Management and contribute to high-quality, regulatory-compliant clinical trials.
Clinical research coordinator specializing in documentation , patient recruitment and trail- related tasks .proven track record in managing research documentation , ensuring compliance and contributing to successful clinical trial execution .