Nicole McGrew

Nicole McGrew

Senior Director Clinical Affairs, Neuro
Background

Nicole has over 26 years of experience in clinical research, having started as a clinical research associate and moved to roles of escalating responsibility. Nicole has strong leadership skills and a proven delivery record with extensive experience in projects and programs spanning across the globe. Nicole has primarily worked in Neuroscience (including Analgesia, Epilepsy, Movement Disorders, Psychiatry and Rare Disease) therapeutic areas. She has worked in several other therapeutic areas, on programs with new emerging treatments, understudied indications and first in-class treatments, wearable technology, application platforms and neurology devices.

Education

Nicole obtained her bachelor’s degree in organizational management from Virginia Intermont College and has completed over 40 credit hours toward her master’s degree in project management from Colorado Technical University.

Experience

Prior to joining MCRA, Nicole has worked with small, mid-sized and large CROs beginning as a CRA and progressing in roles of elevated responsibility. Having been in the industry for over 26 years, she has worked in project leadership for over 20 years. Nicole has worked with start-up biotechnology, mid-sized and large pharma companies. She has managed programs where first-in-class medications and technology have been studied, as well as new or understudied therapeutic indications and has worked with adult and pediatric populations.

Nicole has been through many inspections with several different regulatory bodies across the globe after successful delivery of clinical development programs.

Overview

At MCRA, Nicole leads the Neuro CRO operations, collaborating with many stakeholders across the organization to help support all aspects of trial delivery and also works with her regulatory counterparts to ensure the utmost success. Nicole works closely with Sponsors in developing strategies to efficiently operationalize and de-risk clinical research studies in complex subject populations, on time and within budget. Nicole believes open and transparent communication with clients is the first key to successful partnerships.

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