Mauro - Personal Para Centro De Investigacion

Execute site-level clinical trial operations for Phase II, IIb, and III multinational randomized protocols in full alignment with ICH-GCP standards and local regulatory guidelines.. Manage Investigator Site File (eISF) and regulatory documentation using Veeva Vault eBinder, ensuring complete continuous audit readiness for global CROs and pharma sponsors.. Perform unblinded pharmacy procedures, including Investigational Product (IP) accountability, cold-chain monitoring, preparation tracking, and final reconciliation for global studies.. Execute eCRF data entry and query resolution in Medidata Rave and Medrio for unblinded pharmacy workflows and drug administration logs.. Operate interactive response platforms (Suvoda, Almac, Signant Health, Endpoint, Calyx) for IP kit assignment, inventory management, and shipment confirmation.. Facilitate sponsor monitoring visits (IMV) by providing direct documentation support, eSource verification, and resolving operational findings with CRAs.

Executed 100% remote document auditing and regulatory verification for high-cost specialized pharmaceutical treatments and chronic diseases.. Audited medical records, prescriptions, and coverage documentation to ensure strict compliance with healthcare regulations and internal quality protocols.. Managed complex documentation workflows, resolving high-volume data discrepancies and ensuring audit-ready verification logs.. Demonstrated strong operational autonomy and digital workflow management in a fully remote corporate structure.

Validated medical prescriptions and audited health insurance documentation in compliance with national pharmaceutical standards (2021 – 2023).. Managed product inventory, drug storage traceability, and operational workflows across store management roles (2015 – 2021).