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. Work Setup remote with possible cross-functional collaboration. #J-18808-Ljbffr Scorpion Therapeutics