Sara Nabhan

Clinical Lead @ThermoFisher Scientific

US

Lead and manage end-to-end execution of global Phase I oncology clinical trials, ensuring delivery of all clinical milestones (start-up, enrollment, monitoring, database lock, and close-out) on time and within scope. • Serve as the primary operational leadership contact for sponsors, providing strategic guidance, risk mitigation, and communication throughout the trial lifecycle. • Oversee CRA assignment, performance, training, and quality, ensuring protocol adherence, timely monitoring visits, and high-quality source data verification. • Drive start-up activities, including feasibility, site selection, regulatory submissions, site activation planning, and essential document collection in alignment with ICH-GCP and sponsor requirements. • Develop and maintain study plans, including monitoring plans, risk management plans, and communication plans, ensuring operational effectiveness and trial compliance. • Conduct routine data review, trending, and issue escalation to ensure early identification of safety signals, protocol deviations, and data inconsistencies—critical in first-in-human oncology studies. • Lead cross-functional study team meetings and ensure alignment with Clinical Trial Managers, Medical Monitors, Data Management, Regulatory Affairs, and Safety Teams. • Support budget oversight, contract management, and vendor coordination (central labs, imaging vendors, PK/PD labs, eCOA, etc.). • Ensure CRAs are adequately trained on protocol complexities such as dose escalation/expansion cohorts, DLT windows, PK sampling schedules, and safety reporting requirements. • Provide real-time mentorship and ongoing performance feedback to CRAs to improve monitoring quality, site engagement, and issue resolution. • Perform complex risk assessments and implement proactive contingency plans to address enrollment challenges, site performance issues, and patient safety concerns. • Track and manage enrollment metrics, screen failure rates, DLTs, deviations

UTHealth Houston School of Public Health

Master of Public Health - MPH, Health/Health Care Administration/Management

University of Houston

Bachelor of Science - BS, Biology, General