Associate Director, Clinical Data Management

Role: Senior Clinical Data Management leader supporting global Phase I-IV studies in a biotech focused on autoimmune disease therapies, including CAR T-cell platforms like CABA-201 for SLE, myositis, and systemic sclerosis. Responsibilities: oversee end-to-end data management processes—protocol review, EDC and CRF design, data validation, vendor oversight, database lock, regulatory submissions, and compliance with GxP, FDA, and ICH standards. Lead cross-functional reviews, develop data plans, manage CRO/vendor performance, and contribute to quality and process improvements. Qualifications: Bachelor's in life/health sciences; 8+ years in clinical data management within pharma/biotech; extensive experience leading global studies, managing CROs, and working with EDC, CDISC standards, and regulatory submissions. High-Value: autoimmunity, biologics, cell therapy, Phase I-IV, GxP compliance, CDISC standards, cross-functional leadership, vendor oversight, regulatory support. WorkSetup: remote with possible cross-functional collaboration.