Associate Director, Clinical Data Management

Role: Lead clinical data management for rare disease programs, primarily supporting late-stage (Phase 2/3) trials involving biologics or small molecules, with responsibilities spanning strategy, vendor oversight, data quality, and inspection readiness. Responsibilities: oversee all data management activities from protocol development through database lock; develop and execute data strategies aligned with regulatory standards; manage CRO/vendor relationships, establishing KPIs and reviewing deliverables; ensure data quality and audit/inspection preparedness; collaborate cross-functionally with Clinical Operations, Biostatistics, Medical Writing, and Regulatory teams; drive process improvements and implement innovative data management solutions. Requirements: 8+ years of clinical data management experience within biotech/pharma/CRO settings; 3+ years in leadership roles overseeing outsourced data activities; expertise supporting Phase 2/3 and regulatory submissions; deep knowledge of ICH-GCP, FDA/EMA regulations, CDISC standards, and clinical data lifecycles; strong vendor management, strategic thinking, and communication skills. Preferred: experience in rare diseases, biologics, or immunology. Location: Boston, MA, with hybrid work model (minimum 2 days/week onsite). High-value specifics include focus on rare primary immunodeficiency treatments, late-stage clinical trials, and data quality/inspection preparedness for regulatory compliance.