Consultant specializing in clinical research processes including quality and audit, business transformation, project management and site monitoring.

Designed, sold and implemented major contracts of $1.7B, $500M, and a wide variety of smaller contracts. Directly managed a global team of 10 quality professionals overseeing staff of 2000+ executing more than 700 procedures supporting an average of two audits per month. Accountable for GxP, data privacy, and cross-border quality and compliance, continuous improvement and audit of pharmaceutical, biotech and medical device outsourced customers. Internal and external consulting projects.

Principal consultant on a wide variety of regulated projects including biotech, pharma, medical device, healthcare, and agricultural chemicals. e-Compliance practice manager and solution designer for Electronic Data Collection project.

• Chair, Clinical Research Operations Technology Task Force. Accountable for global standards, implementation and support of new research technologies and platforms including Electronic Data Collection (EDC), Interactive Voice Response (IVR), Clinical Trial Management Systems (CTMS), etc.
• “Firefighter” and Trainer, accountable for the overall quality and performance of western region sites and CRAs
• CRA Certified Mentor
• Singulair product line Technical Liaison

• Selected to Pharmaco-LSR Advisory Board to represent Clinical Research Services to the company, providing field efficiency perspectives relating to corporate policies and procedures
• Awarded “Target 100” by Sponsor for exceptional individual achievement
• Trainer of new personnel in regulations and procedures, including training in the field
• Trainer of new personnel in Phase I procedures and regulations
• Specialist in radio-labeled trials