Award-winning, results and solutions-focused, experienced clinical trials professional with extensive industry experience in clinical project management, operational team management, clinical site monitoring, study start-up and maintenance. Multilingual, fluent proficiency in Spanish and Portuguese. Highly adaptable and creative, skilled in regulatory document review and submission, informed consent review, and contract and budget negotiation. Demonstrated excellence in customer focus, on-time delivery, and keen financial management. Demonstrated ability to promptly learn and apply new policies, procedures, and information according to ICH/GCP guidelines for national and international compliance, adjust to rapidly changing requirements and regulations. Creative, “no-nonsense”, democratic leader of global clinical trials in multiple therapeutic areas including infectious disease (RSV, COVID), NASH/NAFLD, rare disease, oncology, diabetes, and gastroenterology. Self-motivated, driven, and personable with exceptional interpersonal oral and written communication skills. Values transparency, respect, professionalism, mutual accountability, autonomy, and cross-functional collaboration.More...