Katarzyna Ezeasor

Background

About Katarzyna Ezeasor

Senior Clinical Operations & Quality Leader with 20+ years delivering global trials in 30+ countries (oncology, rare diseases, neurology, immunology). Expert in CRO oversight, audit readiness, regulatory compliance (ICH-GCP, EU CTR) and on-time, on-budget project delivery. Driving operational excellence and quality across complex, multi-region studies. Results-driven professional recognized for on-time, high-quality delivery of complex, multi-region studies in both sponsor-led and CRO-delivered models. Core Expertise: • Global Clinical Trial Management – from start-up to CSR delivery • Quality Assurance & Compliance – ICH-GCP, SOPs, EU CTR, ISO 9001 • Vendor & CRO Oversight – eCOA, central labs, imaging vendors • Regulatory Affairs Support – RA/EC submissions, inspection readiness • Budget & Risk Management – multimillion-euro budgets, CAPA implementation Proven ability to lead cross-functional international teams, optimize operational processes, and navigate high-pressure, regulated environments. Experienced in audit preparation, issue resolution, and process improvement to ensure the highest standards of data quality and patient safety. Trusted partner to sponsors, CROs, and clinical sites, committed to operational excellence, quality-driven execution, and strategic leadership that drives trial success.