With over 20 years of experience, Jane Edwards, has a proven track record as a leader in clinical and technical areas of the diagnostics industry. Her experience includes clinical research and operations (global), regulatory affairs, technical services and clinical training. She has successfully managed clinical operations, and authored and executed studies in the areas of cardiovascular, diabetes, nephrology, toxicology and coagulation.
Edwards’ professional interests include product and clinical trial strategy, study protocol development, clinical operations oversight, clinical trial management, market development, project management, regulatory strategy and technical services team implementation and development.
Prior to joining L3 Healthcare, Edwards joined Alere, Inc, a leader in point of care device diagnostics, in 2010 as Principal Clinical Scientist. She advanced to Associate Director of Clinical Operations where she successfully led Alere’s clinical operations team and directed all the day-to-day operations, including oversight of all the studies, management of the entire department budget, as well as study budgets, and personnel. Edwards was instrumental in ensuring the advancement of the company’s clinical trial strategy, and compliance with FDA regulations and ICH-GCP guidelines. She also worked closely with Regulatory Affairs focused on developing optimal strategies for FDA pre-submissions of new diagnostic products.
Prior to Alere, Edwards joined CLINDEVOR TriMed, Inc. as Vice President, Clinical Services where she advanced the clinical trial operations of the company, managed several large in vitro diagnostics clinical trials, and lead the team of Clinical Research Associates. Her role included all aspects of clinical operations to include the development and design of trial protocols, development and maintenance of the trial budgets, contracting, clinical sites, and execution of clinical trials. Edwards monitored clinical sites in the U.S., EU, and New Zealand.
Edwards previously worked at Biosite Inc. as Senior Regulatory Affairs Specialist where she served as a liaison with the State Departments of Health and was, responsible for ensuring the Company’s operations were current with CMS and CLIA regulatory requirements. Edwards also served as Manager of Technical Services where she established and lead a world-class technical services team to support the Company’s global point of care diagnostics market.
Edwards holds a Bachelor of Arts degree in Psychology, with minors in Chemistry and Biology from the University of California, San Diego. Edwards earned credentials as a certified Clinical Research Associate (ACRP) as determined by the Academy’s FDA CRA Exam Committee and is currently a member of the Association of Clinical Research Professionals (ACRP), the Society of Clinical Research Associates (SOCRA) and RAPS (Regulatory Affairs Professionals Society).