Jane Marie Johnson

Jane Marie Johnson specializes in remote and onsite consulting services for medical device firms with a focus on risk-based study monitoring, centralized review/analysis, site training (ISO14155, GCP), SOP development and clinical study project management. She also performs database audits and provides services to assist with conversion from paper to electronic TMF. Ms. Johnson has therapeutic experience in ophthalmology, interventional cardiology, interventional radiology/vascular surgery, oncology, and gastroenterology. She has managed all aspects of clinical trials through PMA submission, including IDE study design and data collection at 40+ sites.