Ms. Leslie Sam BA, CSSBB, CQIA

Leslie Sam, President of Leslie Sam and Associates, LLC, brings over 25 years of expertise in clinical trial research, quality management, and leadership roles. As a Six Sigma Black Belt, she drives transformative solutions in the design and implementation of clinical quality management systems (CQMS), with a strong focus on building a culture of quality at every level. Leslie's strategic approaches incorporate regulatory guidance and industry-leading practices, enabling organizations to implement risk-based quality management (RBQM) and other forward-thinking practices in clinical trial execution. Recognized for her expertise, she was sought by TransCelerate Biopharma to co-develop and co-author the industry's conceptual frameworks for CQMS and issue management. She also contributed as a reviewer to TransCelerate's risk management framework, leveraging her deep knowledge to influence industry standards. Leslie is widely known for applying strategic and tactical risk-based approaches that ensure data integrity, patient safety, and compliance in clinical trials.