CTM
Worldwide Clinical Trials
Jan 2018 - Current (8 years 6 months)
Accomplished Clinical Operations Leader (RN, BSN) with 15+ years of progressive experience in international Phase I–IV oncology and cell/gene therapy trials. Demonstrated expertise in in-house management of all trial aspects, ensuring the rapid delivery of high-quality data, on time and on budget. Adept at leading multi-country teams, collaborating across cross-functional teams (Data Management, Regulatory, Clinical Science), and developing operational strategies for complex CAR-T protocols. Proven track record in audit-ready operations, risk mitigation, and rigorous adherence to ICH-GCP and FDA guidelines.
• Managed prior authorizations and insurance verifications to ensure timely patient access to investigational therapies, streamlining