Iris Cuentas garcia

I've managed Trial Master File activities for Emmes Group, formerly VaxTrials, supporting global Phase III vaccine studies across multiple countries and investigative sites.

I review, classify, file, reconcile, and resolve queries for essential clinical documents in Veeva Vault eTMF. My work includes metadata, naming conventions, document quality, sponsor requirements, and final TMF delivery.

As CTA Lead during the close-out of two global Phase III vaccine studies, I coordinated CTA deliverables, tracked priorities and deadlines, and supported TMF quality and completeness metrics of approximately 90% or higher.

Across clinical research coordination roles at Endocare and SOHEC, I've maintained regulatory binders, supported Phase II–IV studies, managed Ethics Committee and Regulatory Authority documentation, and worked with safety, protocol deviation, EDC, and IWRS processes.