Elizabeth Bodi has over 29 years of experience in the biopharmaceutical and medical device industries. Her career has focused primarily on clinical operations and clinical quality assurance activities to ensure excellence and consistency across phase I-V clinical trials. Elizabeth also has specific experience in the management of clinical quality assurance programs including site, vendor, and process audits. Additionally, skilled in the implementation of quality system initiatives – such as developing SOPs, conducting gap analyses and remediation, establishing and/or managing quality groups, conducting inspection readiness activities including behavioral coaching and mock inspection, hosting regulatory authority inspections, and the development and delivery of training courses in clinical research management and GCP.
Before joining Halloran, Elizabeth worked in the Clinical Training and Compliance group at Antigenics where she was responsible for the development and implementation of Clinical Trial Management Systems (CTMS), quality assurance, and standard operating procedures. Elizabeth has held roles as a Clinical Research Associate (CRA) at Covance, and Training Manager at PAREXEL International, and MTRA/AAI.