Research Experience

• 20+ years of pharmaceutical industry experience
• Design of interventional and non-interventional trials
• Trial documents including protocol, CRF, ICF, IND, CTA, IB and SAP
• CTA, IND and Ethics submissions
• I am an expert member of the Berkshire B Research Ethics Committee
• Medical, safety and data monitoring of trials
• Oversight of CRO medical activities
• Training of trial teams and site staff
• Analysis, reporting and publication of trial data
• Medical lead and subject matter expert for audits and inspections
• Example 1: Design and implementation of an efficient and flexible safety monitoring process for clinical trials for a top 20 pharma company. The solution was adopted across the company.
• Example 2: Designed and used novel data review and cleaning methods to fast track analysis of key events in large scale vaccine study for a top 5 pharma.