Michele O’Connell was awarded an MSc in Clinical Pharmacology from University College Cork before joining Glaxo as a CRA before promotion to Clinical Trials Manager. After a decade with Glaxo, Michele joined Java Clinical Research in 2002 as a Senior Manager. In Java, Michele works in project management and business development, and has particular responsibility in the company for regulatory compliance. Michele is responsible for the development of Java’s quality systems including writing, implementing and training staff on standard operating procedures. Michele is also an active member of The Research Quality Association (RQA, formerly BARQA).