Clinical research Professional
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Results-driven Clinical Research and Regulatory professional with 10+ years of experience in end-to-end clinical trial management, QMS implementation, and regulatory compliance. Proven success in monitoring, documentation management, and cross-functional leadership within CTMS, eTMF, and EDC systems. Skilled in ensuring adherence to ICH-GCP, FDA, EMA, and CDSCO standards and leading teams to achieve project excellence
Results-driven Clinical Research and Regulatory professional with 10+ years of experience in end-to-end clinical trial management, QMS implementation, and regulatory compliance. Proven success in monitoring, documentation management, and cross-functional leadership within CTMS, eTMF, and EDC systems. Skilled in ensuring adherence to ICH-GCP, FDA, EMA, and CDSCO standards and leading teams to achieve project excellence.
Good experience in Clinical operations,QMS,Clinical Data management and Regulatory Department.
M.Pharmacy completed at Anna university