Steven Mangum - Quality Director

Over 28 years of global experience in clinical trial development. Experienced in Phase I to Phase IV studies in oncology and hepatology studies including the deployment of trial related technical documents (e.g., clinician protocol, investigator brochures (IB), clinical study reports), and managed joint sponsor clinical studies with both the NIH and NCI.

As QA Manager and as QA Director, responsible for oncology audit schedules for all oncology assets. Created quarterly reports to summarize site and vendor audit findings and trends. Conducted audits of clinical trial sites, clinical laboratories, and other third-party vendors. Responsible for internal Corrective Actions and Preventative Actions (CAPAs). Hosted global inspections of sponsor and clinical trial sites by FDA, EMA, Health Canada, and PDMA across multiple therapeutic development areas (e.g., vaccines, neurotology).