Deborah Barber

Background

About Deborah Barber

Clinical Operation Lead/CSM for global Phase I/IIa Alzheimer’s Research Study. Skills include E2E study management, clinical trail systems (CTMS, eTmf, EDC, IxRS) contracts/budget management, Vendor oversight and problem resolution. Agile and Global Team member experience. Prior Site level management: Experienced Clinical Trial Manager and Team Leader. Oversight of research infrastructure administration group who provided support to 100+ concurrent research projects, ranging from Phase I-IV, IND/IDE and observational trials. In this role, I served as initial point of contact (Internal and External sponsors) for the pre and post award activities of conducting clinical trials, from initial contact, study implementation processes and all administrative activities through study closure. Managed and tracked key study metrics to ensure adherence to project milestones, report preparation and presentation to senior leadership/stakeholders. Administrative oversight of 7 divisions and multi-site projects. As Clinical Trials Manager, I ensured accurate budget negotiations, post award oversight, and monitored third-party vendors performance. Other tasks performed in this role encompassed oversight of regulatory submissions, monitoring for protocol deviations, establishment of SOPs, timely reporting to regulatory entities, establishment of Site Trial Master File, audit preparation, problem solving, risk mitigation and timely escalation of issues to senior leadership and stakeholders. Worked often in matrix environment with cloud application for collaborative and complexed projects.