Rebecca has worked in the clinical research field for the past 15 years. She has led clinical operations activities in both the pharmaceutical and medical device industries. Her experience includes clinical operations department leadership, new process creation and training, clinical compliance and GCP leadership, TMF and CTMS development, inspection readiness leadership, hosting regulatory inspections, internal auditing, and CAPA ownership. At Astellas, Rebecca leads inspection readiness for the Clinical Operations organization, supports study teams in identifying, mitigating, and solving clinical trial issues, manages compliance-related activities including CAPAs and audits, and develops key clinical operations procedures and tools.
