Deborah Mange

About Deborah Mange

With over 14 years of experience in the clinical trial and CRO industry, I am a seasoned and passionate Sr. Manager of Clinical Operations at NAMSA, the leading global medical research organization. As a registered nurse with a strong clinical background, I have a deep understanding of the medical device and biologics field, and the regulatory and operational challenges that come with it. My core competencies include regulatory compliance, project management, budgets and contracts, audit preparation, SOP and training development, monitoring, CEC and DSMB coordination, EDC and CRF development, personnel line management, site feasibility and study start up. I have successfully led and supported multiple clinical studies across various therapeutic areas, phases, and regions, delivering high-quality results and exceeding client expectations. I have also presented in the industry on topics ranging from monitoring to regulations and device trial conduct. My mission is to advance medical science and improve patient outcomes through innovative and ethical research.

Experience

1. Associate Director Clinical Operations

   NAMSA

   Jul 2024 — Present

Education

• Indiana University Bloomington

  BSN

  1982 — 1986

Skills

• Healthcare
• Edc
• U.s. Food and Drug Administration (Fda)
• Nursing
• Protocol
• Gcp
• CRO
• Management
• Sop
• Regulatory Affairs
• Clinical Development
• Training
• Good Clinical Practice (Gcp)
• Ich-Gcp
• Ctms
• Research
• Cardiology
• Hospitals
• Fda
• Life Sciences
• Medical Devices
• Leadership
• Oncology
• Pharmaceutical Industry
• Biotechnology
• Clinical Trials
• Healthcare Information Technology
• Clinical Monitoring
• Clinical Research