George Hollen

Senior Project Manager @Endpoint Clinical

Wilmington, NC, US

Lead the design and implementation of complex Clinical IRT/RTSM projects, acting as a subject matter expert on client clinical study protocols to translate requirements into precise system specifications, with a focus on randomization schemas, stratification logic, and site/subject management. Oversee the configuration and testing of IRT systems to guarantee alignment with protocol requirements and uphold data integrity. Serve as the primary point of contact for clients, ensure client satisfaction by providing timely updates on all project developments and managing expectations. Create and maintain project timelines, budgets, and milestones; Provide ongoing project health and profitability reports to stakeholders. Manage issue resolution for studies in maintenance, including troubleshooting and root cause analysis. Contribute to the standardization of project management artifacts, including test plans and user acceptance testing (UAT) documentation, to support consistent and high-quality IRT implementation. Build effective partnerships with diverse internal and external clinical teams to ensure alignment and efficient data flow between IRT and other clinical systems. Participate in and/or lead training and mentoring efforts for project team members, sharing expertise in IRT/RTSM best practices. Operate as a specialist in vendor integrations and data transfers, including Electronic Data Capture (EDC) systems (e.g, Veeva, Zelta, Medidata Rave, Clario), Clinical Supplies Systems (Almac, Fisher, PMD). Participate in Client Audits as the point of contact for any study related questions.

East Carolina University

Bachelor of Science (BS), Industrial Technology

E.A. Laney High School

Diploma

University of North Carolina Wilmington

Masters, Business Administration