Experienced Drug Development Business and Information Technology Leader with proven track record of successfully partnering with global business colleagues and internal/external suppliers to develop to deliver drug program submissions through operational excellence, and to develop new capabilities through process re-engineering, implementation of standards and leveraging digitalization to modernize Drug Development processes and deliverables. Demonstrated success building industry-wide collaboration and digital transformation through my leadership of the TransCelerate Digital Data Flow initiative, working closely with CDISC to develop next generation digital protocol standards enabling end-to-end interoperability from study design through submission. End-to-end knowledge of drug research and development processes joined with proven expertise in strategic and tactical analysis, information technology, solution delivery, system support, clinical data management and reporting, clinical data standards, clinical trial operations, shared business services, outsourcing, regulatory compliance, system validation and risk management.

Session:

• The Positive Impact of Digital Protocols on Research Sites