Michele O.
Clinical Research and Quality Assurance Professional
Management of multiple world-wide clinical trials in the therapeutic areas of cardiology, pulmonary, neurology, aesthetics, women’s healthcare, and peripheral vascular applications. Development and management of Quality Assurance System (SOPs, controlled forms, work instructions, study plans, and other study related procedures and systems.) Conducted sponsor audits for compliance with applicable regulations and standards, such as Good Clinical Practice (GCP) guidelines, FDA regulations, ISO 14155, Declaration of Helsinki, internal company SOPs and other internal company procedures. Development of Clinical Investigational Plans and Study Support Documents. Management and coordination of clinical trial Core laboratories, Clinical Events Committees (CEC) and Data Safety Monitoring Boards (DSMB). Development and management of company Quality Management Systems (QMS). Management of Clinical Trial site start-up, management, monitoring and close-out of multiple clinical sites. Managed data management / data handling for various study sponsors. Participated in FDA inspection.
Earnings and projects
An estimate from an earlier read
Earnings, last 30 days
Dotted: longer than usual between two readings.