Debbie Mange has over 15 years of experience working with medical device clinical trials. This includes clinical study management and monitoring, site management and monitoring, supporting global regulatory submissions, site and Sponsor inspection readiness and support in both contract research organizations and industry. She has managed teams of clinical study managers overseeing a wide variety of studies from early feasibility to post-approval. Her experience includes Investigator Sponsored Studies and working with products approved under Humanitarian Device Exemption (HDE). She currently provides oversight of the monitor and site support teams at NAMSA. Debbie is an RN and graduated magna cum laude with her BSN from Indiana University.

CORE COMPETENCIES

• Providing leadership and management to Clinical Study Manager and Monitoring teams
• Managing clinical research activities from protocol development through clinical trial execution and communication of results
• Experience with clinical studies for early feasibility, pivotal and post-market medical device studies in a variety of therapeutic areas
• Developing training plans, resources and providing quality oversight and mentoring to ensure effective study monitoring
• Preparing and supporting sites and Sponsors for audits and regulatory inspections
• Supporting sites to develop and implement good clinical practices that ensure human subject protection, compliance with the regulations and accurate data reporting throughout the study
• Ensuring clinical studies are conducted according to applicable ethical principles, regulations and procedures

RECENT PROJECTS

• Provided Sponsor audit preparation and provided front room FDA BIMO inspection support for a successful audit with no observations
• Supported a rescue study implementing plans to review multiple sites and data to bring the study and sites into compliance resulting in a successful PMA submission
• Managed and led a team of clinical study managers running 50 clinical studies across 15+ therapeutic areas including IVD, novel device, non-significant risk Class II and Class III devices, first in human, decentralized clinical trials, Investigator-Sponsored and post-market studies