Resourceful, insightful, and self-directed executive, with strategic visioning and expertise in global and clinical operations, administrative management, and clinical research. Extensive background in healthcare, FDA inspections and audits, obtaining high quality results with safety-centered clinical trials, risk analysis and mitigation, regulatory compliance, and implementing global initiatives that drive transformation and positive outcomes. Critical thinker, solutions-focused, and results-driven, with excellent interpersonal communication skills, cross-functional team leadership and collaboration, robust task ownership, and a strong work ethic. Resolves issues, develops staff into performance-driven employees, and drives change, innovation, and operational improvement to achieve key deliverables. CORE COMPETENCIES: Clinical Trials | Clinical Research | Clinical Operations | Global Operations | Budgeting | Grants | Operational Improvement Program Management | Strategic Planning | SOPs | Best Practices | Risk Assessment/Mitigation | Regulatory Compliance Neurology | Radiology | Pediatrics | Lymphoma | Immunotherapy | Electrophysiology | Vascular Surgery Medical Devices | Healthcare | Nursing | Biotechnology | Interventional Cardiology | Oncology | IDEs | Submissions | FDA Requirements Analysis | Resource Planning | Recruitment | Team Building/Leadership | Staff Development | Training Analytics | Facilities Management | Capital Equipment | Contracts | Diversity & Inclusion | English, Italian TECHNICAL SKILLS: MS Office | OnCore | EPIC | Prism | Slack | Google Workspace KEY ACCOMPLISHMENTS: • Ability to grow an organization from small to mid-size and drive change using a high level of experience and insight, leading to significant improvements in efficiency and outcomes • Conduct and efficiently complete safe clinical trials, taking corrective and preventive actions to ensure safe patient care and consistently delivering trial results • Excel at managing FDA inspections and audits, with very little error and the ability to move clinical trials forward with high quality outcomes