Raju Nair

Associate Director Clinical Data Management @Teva Pharmaceuticals

Bengaluru, IN

Build the process & standards for database programming & Clinical Data Management activities as part of sponsor oversight. • Oversee the data management vendor(s) work and ensure their work meets protocol and regulatory requirements. • Coordinate with clinical leads, clinical study managers and clinical systems manager.• Coordinate and approve programmable protocol deviations specs• Review and approve edit check specifications and review the programming of edit checks in the electronic data capture (EDC) system.• Review and approve validation plan, test scripts and perform validation of the eCRF and edit checks in the electronic data capture system.• Review and approve Data Entry guidelines, Clinical Data Management Reports.• Review and approve data review and oversight listings.• Coordinate and approve User Acceptance Testing (UAT).• Review and approve development of the Data Management Plan (DMP) and other study specific procedures.• Review clinical trial data using listings and perform query management.• Review medical coding and provide inputs.• Review and approve change requests and documentation archival of change requests.• Review and approve interim & final review of subject data, coding, query listing, SAE reconciliation, and Lab data reconciliation.• Maintain compliance of SOPs

Sikkim Manipal Institute of Technology - SMU

M.B.A., Information and Systems

Bangalore University

B.Sc., Biotechnology, Genetics, Biochemistry

University of Wisconsin-Eau Claire

Diploma, Bioinformatics

Modern School

10&12, Science