As an experienced professional in clinical operations, I bring a wealth of skills and expertise to the table. With a meticulous focus on ensuring compliance with FDA regulations, ICH GCP guidelines, and SOPs/Quality. I have successfully managed all aspects of clinical trials, from protocol development to start up, maintenance and closing. My strong leadership abilities have enabled me to effectively lead study teams and foster cross-functional collaboration with external partners. I excel in project management, providing oversight across all study phases and coordinating multiple interfaces to optimize study planning and execution. With excellent communication and negotiation skills, I adapt my approach to effectively address various stakeholders and encourage collaboration within and beyond the team. Adept at problem-solving and decision-making, I anticipate and mitigate study risks while proactively identifying opportunities for improvement. My commitment to operational excellence and people development ensures that projects are delivered on time, with the highest quality, and within budget.