Alagupriya Somasundaram

To Lead DM planning including trial execution and closure for DM activities as Clinical Data Manager, Trial Data Manager, International Trial Data Manager.

To perform the role of Clinical Data Manager, Trial Data Manager, International Trial Data Manager  Trial tool execution and trial business processes, Discrepancy review and management, Review, Interim analysis, Risk management and Standardization. To coordinate and support the main DM roles for the trial in ensuring timely completion of discrepancy management activities for assigned projects following appropriate regulatory guidelines, company and department SOPs.

Trial Set up, Conduct and Closure activties  Trial tool execution and trial business processes, Discrepancy review and management, Review, Interim analysis, Risk management and Standardization.

 Study Contact , as a Team Lead handled a project team of 20 members.  Taken care of due diligence and Transition of Projects Data validation Mentoring the team.  Preparing metrics and reports required to analyze the team performance.  To perform and assign day-to-day data management activities ensuring timely delivery of each task during set-up, maintenance and close-out of the study.

Discrepancy Management, Query generation and Resolution  Edit Check Validation, Protocol, Data Management Plan and Study Specific Procedures review and Training; Other Validation activities including SAE, IVRS, ECG, Lab, Cenduit reconciliation and Coding with MedDra and WHO Drug with proficiency in INFORM, RAVE, ORACLE Clinical, Oracle Remote Data Capture platforms.

Business Administration

Clinical research