Michelle Graves

Background

About Michelle Graves

Michelle Graves is a leader with extensive experience leading and directing cross-functional teams and coordinating global, multi-center, clinical research projects, project teams, and strategic relationships. Since she began her career in clinical research in 2001, Michelle has worked at the site level and with CRO and sponsor. Michelle’s experience primarily sits within project management and leadership. Michelle also has extensive site experience having started a clinical research site (direct to patient) from the ground up. Michelle has experience managing strategic relationships with responsibilities including governance and performance management and oversight; business development, contract, budget, and finance management; site feasibility and start-up; and quality, risk management, and compliance. She has managed and coordinated service lines including clinical monitoring, site management, regulatory affairs, operations quality, drug management, safety surveillance & reporting, RBQM, data analytics and management, biostatistics, medical writing, and third-party vendors. Michelle has strong leadership skills and an excellent proven delivery record across a wide range of large and demanding global projects. She has a cross-therapeutic background including geriatric and pediatric populations. She is well-rounded having experience in hospital (outpatient, inpatient, operating room, PACU, physician clinic), phase I unit, academic facility, US naval base, and American Indian reservation in over 70 clinical trials. Her clinical trial experience includes oral, transdermal, intratympanic injection, IV, IM, and subcutaneous routes of administration under FDA IND, IDEs, and BA/BE. Michelle has traveled world-wide both professionally and personally to at least 25 countries. Michelle earned her BA in Psychology and Sociology in the United Kingdom, after which, graduating summa cum laude from Drexel University College of Medicine in the United States with her MSc in Clinical Research Organization and Management.