Cristina Monastero

Associate Director, Clinical Document Management

Cristina is an enthusiastic TMF cheerleader that champions for clinical quality, compliance, and inspection readiness in all phases of clinical trials. Cristina has held various roles in Clinical Operations, TMF Operations, Clinical Compliance, and Clinical Inspection Readiness at large, mid-sized, and small pharmaceutical and biotech organizations with a focus on implementing global TMF processes and systems. Cristina is passionate about driving the cultural mindset change around TMF from a document repository to a system that assists cross-functional team members with study operations and oversight. Cristina holds a BS in Biological Sciences from Drexel University and an MS in Clinical Research from Drexel University College of Medicine and is passionate about raising awareness of rare disease research. Cristina participates in several industry workgroups focusing on TMF, clinical quality, and inspection readiness.

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