Amanda Slavsky has been in the clinical research industry for over 11 years, with 9 years focused on medical devices. Amanda has extensive experience focused on neurology (CNS, movement disorders) and neurosurgery (stroke, spine, brain tumors, aneurysms) along with ophthalmology, peripheral vascular, and more. She has led complex, multicenter trials from early-phase to post-market, ensuring global compliance with FDA, ICH-GCP, and ISO 14155 standards. She has provided strategic leadership and guidance throughout multiple FDA BIMO audits and site preparations with favorable outcomes.
Prior to joining NAMSA, Amanda was notably the Executive Director of a large nonprofit research organization focused on promoting research and training the next generation of neurosurgeons, neurologists, and neuroscientists. Additionally, she has worked with academic institutions such as the University of Tennessee Health Science Center and the University of California, San Francisco, supporting global trials and regulatory interactions. She holds a B.A. in Molecular, Cellular, and Developmental Biology from the University of Colorado and is a Certified Clinical Research Professional (CCRP) and active member of The Society of Clinical Research Associates (SOCRA).
CORE COMPETENCIES
- Clinical study management
- Neurology & neurosurgery device expertise
- Regulatory compliance (FDA, ICH-GCP, ISO 14155)
- Vendor oversight (CROs, Core Labs, Site Vendors)
- Protocol development & site training
- Risk management & safety oversight (DSMB, CEC)
- Budget & contract negotiation
- Audit readiness & quality assurance
- Cross-functional team leadership
- Global clinical operations
- Training & mentorship for clinical teams
- Inspection readiness (FDA BIMO, Sponsor Audits, CRO Inspections)
RECENT PROJECTS
- Led clinical study management for a pivotal, multicenter trial evaluating a device system for large bore femoral artery access site closure
- Successfully navigated four investigational sites through FDA BIMO audits, ensuring regulatory compliance and data integrity to support ongoing U.S. and EU market access efforts
- Oversaw execution of a pivotal IDE trial of a thrombectomy system in acute pulmonary embolism focused in the United States
- Supported the study to generate pivotal evidence for FDA submission and future market access while supporting the client’s vision to expand current treatment options for patients
- Directed and coordinated feasibility and pivotal studies for complex neurovascular interventions—including stroke, aneurysm repair, fistula repair, and intracranial hemorrhage—at the site level
- Ensured protocol compliance, optimized study operations, and delivered high-quality data supporting regulatory submissions and advancement of innovative therapies
