Gina Ricciardelli

About Gina Ricciardelli

I manage clinical trials with a site-to-sponsor lens, driving clarity, CRA support, and operational execution across oncology and gene therapy studies. My focus is on delivering complex trials through strong site partnerships and streamlined team coordination. I lead cross-functional trial operations from startup through database lock, working across global teams to align stakeholders, close documentation gaps, and mitigate risk. I’ve built study plans, managed vendor partnerships, trained CRAs, and resolved site escalations, ensuring timelines and compliance stay on track. I’ve worked with academic cancer centers, sponsor teams, CRO partners, and SaaS vendors to deliver complex trials. I’ve trained 300+ site staff, partnered with top-tier investigators and institutions, and overseen global CROs across multi-country studies. My roles span sponsor-side leadership, CRO oversight, and field-based collaboration. At Parexel, I led startup and regulatory submissions for a Phase I trial while managing CRA performance through close-out on a concurrent Phase study. At Homology, I managed contracted CRAs and redesigned CRO project plans to improve oversight. At AstraZeneca, I earned audit recognition as lead CRA on a Phase II lung cancer trial through early KOL engagement and proactive monitoring. • Study Startup Through Trial Close-Out• CRA Oversight & Site Engagement• Oncology, Rare Disease, Gene Therapy• Veeva Vault • RAVE • Oracle Clinical • InForm• Global Vendor Management• Protocol Execution & Risk Mitigation• Cross-Functional Team AlignmentLet’s connect if you’re building clinical teams that value strong execution, system fluency, and collaborative oversight across the full trial lifecycle.

Experience

1. Clinical Team Lead

   PSI CRO

   Aug 2025 — Present

   Responsible for managing the workload and monitoring capacity of 9 CRA\'s in North America on Phase II Advanced Solid Tumor Radiopharmaceutical trial. Coordinates the planning, resourcing and other Line Manager related tasks.Ensures Monitoring Plan and visit schedules are in line with long term strategic goals and timelines of the study. Responsible for trip report review and finalization and ensures compliance with Monitoring Plan. Leads the Country Clinical Team calls at the Project level. Oversees the Protocol Deviation Monitoring Plan in collaboration with Cross functional teams, and including reviewing, management and reporting.

Education

• University of New England

  MS; incomplete, Physician Assistant

• University of New Hampshire

  Bachelor of Science - BS, Health/Health Care Administration/Management