Freelance Lead/Srcra Spain Regulatory Consultant - Ctis Expert

Freelance Lead/SrCRA Spain Regulatory consultant - CTIS expert possesses extensive experience in clinical operations and regulatory affairs, specializing in study start-up and monitoring. Currently serving as a Freelance Global Study Start-up Associate with Advanced Clinical since July 2022, focusing on Ethics Committee and Competent Authority submissions in Spain. Previous roles include Clinical Operations Manager at PMC PARTNERS RESEARCH SL, Freelance SrCRA at HOYA Surgical Optics and PSR Orphan Experts, and Site Relationship Lead at KBP Biosciences. Demonstrated expertise in regulatory and monitoring activities, including significant contributions to a COVID-19 vaccine phase 3 trial with IQVIA and support for expanded access programs. Academic credentials include a Master’s in Clinical Trial Monitoring from Universidad Autónoma de Madrid and several certifications in clinical project management.