Nick Hryciw

WORK HISTORY

EDUCATION

ABOUT NICK HRYCIW

Strategic leader in clinical operations with 19+ years in pharmaceutical, CRO, biotech, and start-up environments driving trial excellence. Proven ability to build and lead high-performing teams, drive strategic planning, drive clinical quality assurance, mitigate risks, and optimize clinical trial operations to meet standards of excellence within Clinical Operations. Expertise in both in-house clinical execution and CRO outsourcing across global trials, with strong EU and Asia experience. Demonstrated success in managing teams through complex projects while ensuring regulatory compliance, operational efficiency, and implementing improvement initiatives. Dedicated to fostering a culture of excellence and collaboration to transform clinical operations environments toward improved performance and optimal trial execution outcomes and business operations.Demonstrated Skills:• In-house global clinical trial execution, oversight, and vendor management• Outsourcing and CRO oversight• Strategic planning, risk mitigation, and problem solving• Line management, career development, and performance evaluation• SOP development, process improvement, and regulatory compliance• Regulatory inspections: preparation, participation, & response, including CAPA development & execution• Rare disease and complex clinical trials • Clinical data management and EDC database development• ICH-GCP, FDA regulations, and global clinical trial guidelines• Cross-functional leadership, stakeholder engagement, and effective communication • Fiscal management, including budget oversight• Project Management• Clinical Quality Assurance• Risk management & quality assurance