Sean Fleming

Background

About Sean Fleming

I apply my knowledge of FDA regulations and Good Clinical Practice (GCP) to the regulatory tasks required for each of the dozens of oncology studies I manage, while my experience with biospecimen collections, repository management, training, and monitoring in Phase I - IV research avail me as a resource to study team members with diverse roles. I work independently on submissions to institutional review boards to keep the research on track and maintain essential documents for the Investigator Site Files in audit-ready condition, while working collaboratively with team members both on site and remotely (Teams, Zoom, WebEx) to resolve sponsor queries and participate in regulatory and study team meetings from the site initiation visit to the close-out visit.