CAREER HIGHLIGHTSCreated and lead a team of 14 international regional CRA subject matter experts (SMEs) to oversee technology issues in the field and provide regional staff access to a SME for immediate technology system and process question resolution. Activities included: hosting monthly web based training for field staff (ask the expert), new hire training on monitoring technologies, PQ and UAT software testing.Facilitated an on site PMDA inspection conducted at two sites within the US.Supported the implementation of 2 EDC systems in person for Wyeth’s Japan office (3 months 2005, 2 weeks 2008). Co-Lead the design and piloting of Wyeth’s Sample Based SDV methodology. Created guidance documents related to monitoring and site staff applications used by support personnel. Ensures consistent and accurate information is provided to end users calling the help deskProvided CTMS and other monitoring-related applications interpretation and support to field-based staffOversaw US CRA hardware/software equipment needs including hardware/software acquisition, laptop & remote access needs, upgrade initiatives and break-fix issues. Assist with coordination of standardizing field based machines for North and South America.Represented the monitoring functions for SOP review and process development meetings Trained and supervised team of 21 Site Management Clinical Research Associates (CRAs) for a 24,000 subject, Phase III Clinical Trial to ensure compliance, review project-related SOPs, enhance communication and increase productivity.Specialties: Implementation of new software and technologies for monitoring. Developing training programs, implementing training programs, presenting, project management, conflict resolution, and technical support.