Jasmine Diaz

About Jasmine Diaz

Strategic clinical operations leader with nearly 10 years of experience in pharmaceutical…

Experience

1. Euctr Manager, Global Site Start-up

   Regeneron

   Mar 2022 — Present

   Responsible for planning and delivering EUCTD/R reporting according to Part II requirements outlined by the EMA via CTIS. • Coordinate with internal and external Regulatory Affairs, Clinical Trial Management, and Clinical Transparency to plan the Clinical Trial Application (CTA) clinical trials that involve EU countries, determine key study milestones and country allocation strategies, and address redactions required for relevant documents identified for CTA submissions. • Identify the list of Member States participating, identify the key study level and Member State/country level milestones that represent Study Start, Study Completion, Enrollment Start, Enrollment Completion, and any potential hold/restart/cancel dates that may apply to the study and capture the relevant information within the CTIS database. • Identify the Institutions and Primary Investigators and capture relevant contact information, locate the documents deemed applicable at the Member State/country and/or site level for CTA submissions, and upload them into the CTIS database. • Triage any questions that surface (RFIs) due to capturing and/or reporting on REGN clinical trial applications. • Engage and oversee any vendor to collect, enter, and maintain relevant information regarding CTAs via the EMA CTIS database.