ROCHELLE Greenbaum

Oversaw Phase I, Phase II, and Phase III studies in various therapeutic areas, ensuring alignment with strategic goals. Served as a Subject Matter Expert for FDA and EMA inspections, managing clinical program budgets and identifying process improvements.

Led global Phase I, Phase II, and Phase III CNS studies, overseeing CROs and managing study budgets. Directed site startups, ensuring timely regulatory submissions and efficient supply chain management.

Served as Lead Clinical Scientist for a Phase III fibromyalgia study, ensuring compliance with FDA regulations and ICH guidelines. Managed a Clinical Trial Assistant and coordinated the review and approval of study documents.

Responsible for the selection, initiation, monitoring, and close-out of clinical sites for Phase I-III trials in cardiovascular and pediatric gastroenterology. Participated in protocol review and CRF development, and mentored junior CRAs.

Managed clinical trials for a CRO in therapeutic areas including diabetic neuropathy and infectious disease. Performed initiation, interim monitoring, and close-out visits, and authored various study-related documents.

Completed a Master of Science degree focusing on Environmental and Occupational Health Sciences. Gained in-depth knowledge of health and safety principles relevant to various work environments.

Obtained a Bachelor of Arts degree in Psychology. Developed a strong foundation in psychological theories and research methods.