Global Clinical Operations Leader and physician with over 9 years of experience specializing in the strategic initiation and delivery of complex clinical studies. Proven track record of successfully leading international projects and inspiring cross-functional teams to ensure trials meet strict timelines, budget, and quality standards required for Phase Ib-IV clinical development. Deep expertise in clinical study management processes, including risk mitigation strategies, CRO oversight, and budget forecasting. A strong, influential leader skilled in coaching and mentoring high-performing teams and ensuring studies are consistently inspection-ready while contributing to clinical operations process innovation. Comprehensive knowledge of ICH-GCP and global regulatory requirements.
Experience
Global Study Leadership & Strategic Oversight
Strategic Study Management (Phase Ib-IV): Extensive experience in managing all stages of clinical trials from start-up through close-out, ensuring alignment with strategic goals and quality benchmarks.
Cross-functional Team Leadership: Proven ability to lead and guide cross-functional study management teams, driving decision-making and fostering collaboration across internal and external stakeholders (including Health Authorities, Ethics Boards, and CROs).
Risk & Quality Strategy: Expertise in developing, maintaining, and overseeing comprehensive quality risk strategies and essential study plans to drive robust clinical study execution and compliance.
Regulatory & Inspection Readiness: Strong knowledge of global clinical research regulatory requirements (ICH-GCP, EU CTR) and demonstrated ability to maintain studies in a state of inspection-readiness, having acted as a primary liaison during audits/inspections.
Budget, Vendor & Financial Management
Budget Oversight & Forecasting: Direct ownership and oversight of multi-million-dollar study budgets, including detailed re-forecasting, financial reporting, and identifying and mitigating financial risks throughout the study lifecycle.
CRO & External Partner Management: Highly skilled in managing external service providers (CROs, central labs), including overseeing contractual obligations and holding vendors accountable for delivery within agreed-upon timelines and budgets.
Contract Management: Experienced in site budget negotiations, contract execution, and managing pass-through expenses to ensure financial alignment and compliance.
People Leadership & Process Improvement
Team Leadership & Mentorship: Strong track record of people leadership, coaching, and mentoring large teams of clinical research professionals (up to 25 CRAs) to foster a growth mindset and professional development.
Process Improvement & Innovation: Contributed to process optimization and innovation in clinical operations, including streamlining start-up processes and automating document tracking to accelerate site activation timelines.
Technology & Compliance: Proficient in clinical trial systems (Veeva Vault, CTMS, RIM, RAVE) to ensure system uptime and operational excellence.
Education
Masters in Oral Medicine and Head and Neck Radiology
