Local Study Associate/Principal Clinical Research Associate - Cell and Gene Therapy | Local Study Associate/Principal CRA - Cell and Gene Therapy

Job Summary

This is a pivotal, client-embedded role within a leading bio-pharma company, focusing on the delivery of clinical studies in the innovative field of Cell and Gene Therapy. The professional will lead local study teams, ensuring all components of clinical trials are executed according to budget, timelines, ICH-GCP guidelines, and local regulations. Key responsibilities include overall accountability for country-level study commitments, coordinating site selection and qualification visits, managing regulatory submissions (EC/IRB and Regulatory Authority), and overseeing monitoring activities from activation through closure. The role requires strong leadership skills to optimize local study team performance, manage financial agreements, and proactively identify and mitigate study risks. Occasional site monitoring may also be required, making this an ideal position for a seasoned CRA looking for a leadership role with hands-on clinical trial management.