Upen Mehta

Background

About Upen Mehta

11+ Years of Clinical Data Management experience in Set up of clinical trials in RAVE, Inform and Oracle Clinical. Worked on all phase EDC/Paper trials and possess strong understanding of Clinical Data Management processes. Manages the design, documentation, testing and implementation of clinical data collection studies, and clinical database review. Collaborates and coordinates with the clinical team to design and implement clinical protocols and data collection systems. Manage data management issues by reviewing protocols for cross-project consistency and identifying standard case report form modules to meet objectives. Provides strategic input into protocol design focused on data management issues. Reviews and resolves data discrepancies for standardized data validation systems and procedures. Collaborates with clinical, biostatistics, statistical programming, and regulatory teams on CRF design, edit check specifications, data review and processing documentation, data transfer specifications Provides CRO oversight to ensure that data management tasks remain on target according to project timelines. Works with vendors, managing all study data to ensure completeness, accuracy and consistency of data for analysis. Contribute to the development and implementation of departmental policies, standards and process improvement initiatives Train Investigators and Monitors for CRF and Safety Data Capturing in EDC. Specialties Project Management- Defining project timelines for building different IT (RAVE. Inform, OC etc) systems and integrations to the different IT system (IV/WRS, LAB). Ensuring deliverables are met as per the timelines defined. Vendor Management : Coordinating with different vendors like LAB, IVRS, Study set up group etc Technical Skills: Medidata Certified RAVE Programmer Strong Set up knowledge on RAVE, Inform,Oracle, J-Review, SQL,Crystal reports and Oracle forms and reports.