Karen L. Roberts, CEO
Karen Roberts brings 20 years of unique experience in both the clinical and business sides of the healthcare industry to the helm of Ars Clinica. Her passion for the work, substantive clinical background, and sophisticated, market-focused perspective, affords her a unique ability to understand, communicate and positively affect the long-term needs of her clients. Known for her pragmatic, holistic approach, she has an exceptional record of exceeding projected timing milestones and increasing her clients' bottom line results. Adept and experienced at strategy, implementation, and post-market work, Karen takes a total solution approach to every facet of the work.
Before launching Ars Clinica, Karen developed a successful clinical and regulatory strategy for Boston Scientific (formerly Guidant) Corporation's Cardiac Surgery Division, for positioning their cardiac surgery ablation therapy. She established significant new relationships with key opinion leaders focused on the advancement of treatment for atrial fibrillation through early research and clinical studies.
Karen also established and directed the research department for Ventrica, Inc., coordinating planning, study design, implementation, data management, monitoring, statistical analysis, and reporting to successfully bring the MVP® first generation and MVP® second generation implants to market in Europe. She also directed the second generation implant Design Dossier review, gaining CE Mark approval in a tight timeframe. Karen later consulted for Ventrica in support of the clinical audit of the Ventrica acquisition by Medtronic Inc.
Her successful PMA experience at Arterial Vascular Engineering (now Medtronic) led to a significant increase in revenue immediately post-approval; she is also well-versed in PMA supplement and 510K work. Karen has also developed and implemented employee education and sales force training programs focused on both customer and patient. Her background includes clinical trial management and technical writing, as well as substantial clinical field experience as a member of cardiac health care teams. She has managed a wide variety of projects, including large randomized studies, and multiple concurrent studies. She travels extensively as part of clients' training and marketing teams. In recognition of her high caliber discernment, resourcefulness, and her fresh approach to business building, Karen has received numerous accolades.
Karen has a Bachelor of Science in Nursing from Carlow College and an MBA from the University of Phoenix.
View Karen's complete resume as a PDF: KLRresume.pdf