Associate Director, Central Monitoring

Role: Lead the design, implementation, and operational management of the company's Risk-Based Quality Management (RBQM) strategy within clinical trials, acting as the primary architect for central data surveillance to shift from traditional data review to proactive risk-based monitoring. Responsibilities: chair the Clinical Data Quality and Governance Board, oversee integration of multi-vendor data streams into surveillance platforms like Veeva RBM, manage process documentation (SOPs, RACT), escalate systemic issues and collaborate with Clinical Operations on mitigation, and drive cultural change toward Critical-to-Quality focus. Requirements: Bachelor's in clinical research, science, or health-related field; 8+ years in clinical research with experience in clinical operations, data management, or biostatistics; 3+ years managing RBQM frameworks; prior supervisory experience. Skills: deep knowledge of ICH GCP E6(R3) and global regulatory standards (FDA, EMA), expertise in risk-based monitoring, strong leadership, data interpretation, and proficiency with systems such as Veeva Vault. High-Value: focus on clinical trial data surveillance and quality governance, with international trial experience, remote work setup, and travel up to 20%. The role supports the company's advanced immunotherapy programs, including FDA Breakthrough Therapy-designated treatments for cancer, emphasizing innovative, data-driven quality oversight in clinical development.