HART CLINICAL CONSULTANTS - Key Persons
Job Titles:
- Executive Vice President
- Executive VP of Operations
Jason serves as Executive Vice President at HCC, leading the Clinical Research and Operations teams with a strategic, evidence-driven approach. With 20 years of experience in the medical device industry, he brings deep expertise across clinical research, regulatory strategy, and preclinical development. Jason has held leadership roles in both startups and multi-product organizations such as Medtronic, consistently delivering clinical programs that support global regulatory approvals and market access.
Known for his analytical rigor and collaborative leadership, Jason partners closely with clients to define strategic objectives and execute clinical initiatives that generate high-quality evidence. His expertise spans clinical trial design, operations, regulatory submissions, cross-functional team leadership, and full-spectrum product development. He has supported a wide range of therapeutic areas, including cardiovascular, endovascular, spine, urology, organ preservation, wound care, and respiratory therapy.
Jason holds an MBA from Cornell University and MSE/BSE degrees from the University of Michigan in biomedical and materials science engineering.
Jim Hart - CEO, Founder, President
Jim Hart, the founder, President and CEO of Hart Clinical Consultants, LLC (HCC) has an extensive background in medical device clinical research and sales. With over 25 years of industry experience Jim's expertise extends to managing a high-volume cardiac and endovascular interventional lab. His strategic planning acumen and passion for excellence serve as the foundation for HCC's leadership and guidance.
Before establishing HCC, Jim enjoyed success at the legacy companies Advanced Cardiovascular Systems (ACS) and Guidant Corporation, as well as Abbott Vascular. His unwavering dedication to advancing healthcare drives growth and success for HCC, with a focus on enhancing medical device technology and ultimately improving patient outcomes.
Jim holds a BS degree from the University of Central Florida and is a Certified Clinical Research Associate (CCRA) recognized by the Association of Clinical Research Professionals.
Nancy M. Ouch leads HCC's Safety Management. Nancy is a dedicated leader in safety management with over 15 years of experience in the medical device, pharmaceutical and biotech industry. Nancy focuses on compliance, risk assessment, and advancing safety practices, aligning with HCC's mission for high-quality patient care.
Nancy is committed to fostering a culture of safety oversight and compliance. With a solid background in safety protocols and risk assessment, Nancy ensures that all aspects of operations adhere to regulatory standards. She leverages her experience to implement robust safety management strategies that prioritize team productivity and service integrity, and actively participates in industry forums to stay abreast of emerging safety trends and regulations. Nancy's passion for advancing safety practices aligns with HCC's mission to deliver high-quality, safe medical products that enhance patient care and outcomes.
Nancy holds a biological sciences degree from the University of California in Los Angeles (UCLA) and a health administration master's degree from California State University in Northridge (CSUN).