I am an IRT/RTSM expert and organizational leader with over 30 years of experience as a vendor, business owner and sponsor. I have a broad base of additional experience in the clinical trial arena including clinical operations, IMP packaging, labeling & logistics. My clinical research experience began with my role as a Clinical Studies Assistant at Corning Pharmaceutical Services which included a 6 moth assignment in Singapore. In 1998 I joined ICTI (now Almac) where I built the foundation for my knowledge of IRT and progressed to the role of Director of Clinical Services. I joined Fisher Clinical Services in 2002 to support their entry into the IRT market. While at Fisher I envisioned and created the Office of Program Management, building my skills in packaging, labeling, and clinical logistics. In 2010 I took an entrepreneurial opportunity to become the co-owner and Chief Operating Officer of Verdacom, an emerging IRT firm. In 2014 I took a sponsor role as Director of IRT at Bristol Myers Squibb (BMS), where I transformed the organization’s IRT strategy, approach to deployment, vendor oversight. and regulatory compliance model. While at BMS I completed the integration of two diverse IRT teams after the purchase of Celgene by BMS. This included developing a completely new operating model (with associated SOPs) and structure based on each legacy organization’s best practices and organizational strengths.In 2021 I joined Calyx as VP, Scientific e-Tech Enabled Services. In this role I leverage my experience as an IRT business owner & sponsor to drive excellence in product, project management, and commercialization; Consulted with clients on IRT best practices and emerging trends in the regulatory landscape; Served as an advocate for sponsors within Calyx through expanded partnership engagements; And contributed to the industry as an evangelist for IRT and its proper role in clinical trials.Throughout my career, I have been actively engaged in the promotion of the appropriate use of IRT and best practices through numerous industry meetings as both featured speaker and chair/co-chair. I have been a contributing author to publications such as the Comprehensive Guide to Clinical Materials (International Society for Pharmaceutical Engineering), Applied Clinical Trials, and International Clinical Trials.