A highly accomplished and top-performing clinical operations expert with nearly 30 years of proven success in leading all aspects of clinical operations. Expertise spans outsourcing management, risk mitigation planning, budget and resource management, process and system improvement, and strategic planning. Excels in managing single- to multi-region Phase 1-4 clinical research programs and has specialized knowledge in CNS, diabetes, gastroenterology, oncology, women’s health, inflammation and pain, cardiovascular disease, ophthalmology, autoimmune conditions, and rare/orphan diseases. Additional expertise working with autologous stem cell therapies. Drives success by leveraging exemplary leadership, technical, and communication skills to achieve corporate objectives while upholding industry-leading standards of excellence. Able to offer a diverse skill set with proven ability to thrive in multiple environments (large pharma, small to mid-size biotech and CRO).CORE COMPETENCIES• Global, multicenter clinical trial execution (planning, oversight, management, and delivery).• Phase 1-4 expertise and hands-on experience/management• Driving innovation and efficiencies into design and execution of clinical trials.• CRO/vendor management (both full-service and single-service outsourcing).• Quality and risk management.• Direct line management (hiring, training, performance appraisals, mentoring).• Recruitment strategy and metrics reporting.• Financial oversight and timeline management.• SOP development and maintenance.• Trial master file (TMF) planning and organization.• Sound knowledge of ICH/GCP, industry standards, and global regulations.