I am a physician-trained clinical research leader (M.B.Ch.B., evaluated by IERF as comparable to a U.S. M.D.) with 26 years in CROs and pharmaceutical, biotechnology, and medical device companies. My career has been unusual in that I have held several roles at once: clinical project manager, medical monitor, committee and adjudication lead, and quality compliance officer. That combination lets me see a study from every angle: operational, medical, and regulatory.
Most recently, as Senior Project Manager and Clinical Development Trial Lead at ICON, I directed operations and endpoint adjudication across three global outcomes studies of 4,500 to 8,000 participants each. I oversaw clinical, imaging, pathology, and eCOA vendors and three independent committees. As medical monitor, I ensured eligibility criteria were applied and well documented, and I put protocol deviation management in place across studies in line with FDA’s December 2024 draft guidance. I also built a process that centralizes subject data from enrollment through follow-up, integrating central laboratory, imaging vendor, and CRO data.
Before ICON, I spent nearly 18 years with Fortrea and its predecessor organizations. I managed up to 12 concurrent drug and device studies from start-up through close-out, including budgets, forecasts, change orders, pass-through costs, vendor oversight, and sponsor reporting. I have managed endpoint adjudication (CEC), DSMB/DMC, and steering committees since 2008, including ensuring more than 500 events were adjudicated in 3 months by building validated tracking where no system existed. I co-established a Global Safety Team, authored global drug safety SOPs, and have written many safety and CEC narratives.
Quality has been a constant thread in my career. I served as Director of GCP Quality Assurance, leading a team of 10 to 12, and have hosted 5 FDA inspections, co-led 2 MHRA inspections, and hosted a PMDA inspection, with no FDA 483 observations in 26 years. I lead risk-based audits of sites, vendors, and laboratories, and I deliver GCP and regulatory training with SQA and ACRP.
My therapeutic experience includes cardiovascular, hepatology (MASH), oncology, endocrinology, neurology, and infectious disease, across Phase I through global outcomes and post-approval studies. Early in my career I also conducted epidemiology research on chronic hepatitis B and C in North Africa.
I am interested in remote roles in clinical project or trial management, clinical operations, medical monitoring and safety, endpoint adjudication and DSMB management, and clinical quality assurance. I enjoy complex, high-stakes studies where strong cross-functional collaboration matters, and I am known for handling difficult situations calmly and bringing teams together.
