Greta Maddonni

Pharmacist and Clinical Research Professional with 11+ years of experience across regulated environments, regulatory compliance and clinical trials, including 5+ years specializing in central/remote clinical trial monitoring and site oversight, with hundreds of remote monitoring visits performed in close partnership with CRAs. Experienced in the operational and regulatory execution of multi-sponsor Phase II and III clinical trials across the full study lifecycle, from start-up and maintenance through close-out. Therapeutic experience includes Oncology, Hematology, Immunology/Autoimmune Disorders, Ophthalmology and Infectious Diseases/Vaccines.

Proven track record in risk-based site oversight, regulatory compliance, issue identification and resolution, and cross-functional collaboration. Supported sponsor quality audits and ANMAT inspections with no major findings and consistently received recognition for quality, reliability, proactive risk management, collaboration and delivery ahead of deadlines. Open to Freelance/Contractor CRA, Sponsor-Dedicated CRA, CRO-based CRA, Remote/Hybrid Monitoring, and Clinical Research/GCP Consulting opportunities.

Senior Site Management Associate (Remote Clinical Monitor) at ICON plc (2021-05 – 2026-06)

• Managed remote monitoring and site oversight activities for multi-sponsor Phase II-III clinical trials across start-up, maintenance and close-out.
• Conducted risk-based remote monitoring, real-time clinical data review, site risk assessment and quality indicator surveillance.
• Ensured site compliance with study protocols, ICH-GCP, applicable local regulatory requirements, sponsor requirements and SOPs.
• Identified, assessed, escalated and followed clinical and operational risks through resolution, proactively preventing potential site and study issues.
• Oversaw investigational product accountability, temperature excursions, SAE reporting, data quality, site training and timely issue resolution.
• Worked reciprocally with CRAs across site oversight and monitoring activities, while independently conducting remote monitoring visits and collaborating with investigators, study coordinators, sponsors and cross-functional study teams.
• Supported sponsor quality audits and ANMAT inspections with no major findings.
• Consistently recognized by sponsors for high-quality delivery and achievement of study objectives, frequently ahead of established deadlines.
• Recognized by investigative sites and internal teams for professionalism, responsiveness, proactive risk management, collaboration and problem-solving.

Central Monitoring Associate I at PRA Health Sciences (2021-04 – 2021-05)

Transitioned to ICON plc following PRA Health Sciences' acquisition by ICON in 2021.

• Performed central monitoring risk review, off-site monitoring visits and quality indicator review in accordance with PRA/sponsor SOPs and work instructions.
• Supported protocol compliance, real-time data review, site risk assessment and timely escalation/resolution of clinical trial issues.

Clinical Trials Study Coordinator at Organización Médica de Investigación (2018-10 – 2021-04)

• Coordinated operational and regulatory activities for multi-sponsor clinical trials across multiple therapeutic areas.
• Supported investigators and study teams in protocol execution, subject data collection, CRF completion, query resolution, adverse event documentation and clinical trial systems.
• Maintained accurate and complete study documentation and supported quality and regulatory compliance at site level.
• Built strong site-level clinical research expertise, providing a comprehensive understanding of both investigative-site and sponsor/CRO operations.

Regulatory Affairs & Trade Compliance Specialist at Merck Group - Sigma-Aldrich Subsidiary (2016-06 – 2017-08)

• Managed regulatory and trade-compliance activities for Argentina and Chile, including import permits, licenses and submissions to public authorities.
• Prepared ANMAT documentation for the importation of biotechnological products and contributed to regulatory strategy development.

Compliance - Technical Service - EHS at Sigma-Aldrich de Argentina S.R.L. (2015-02 – 2016-06)

• Supported national and international compliance requirements for product importation and nationalization, including documentation submitted to Argentine public authorities.

Pharmacist in Pharmacy – Universidad Argentina John F. Kennedy (2020 – 2025)

Chemical Technician – E.T. Nº 27 Hipólito Yrigoyen (2014)