Clinical research professional with a strong track record in leading and coordinating early-phase trials (including Phase I CAR-T), managing interdisciplinary teams, and ensuring compliance with ICH-GCP, FDA, and institutional regulations. Adept at patient engagement, cross-functional leadership, and proactive problem-solving. Proven ability to mentor staff, streamline workflows, and contribute to IRB documentation and publication efforts. Seeking a Clinical Trial Manager role to leverage leadership, regulatory insight, and clinical operations expertise.
Clinical trial management
FDA, IRB, GCP compliance
Patient-facing communication
Adverse event reporting
Team leadership and mentorship
SOP development
Cross-functional collaboration
Remote monitoring support