Senior Manager, Clinical Operations

Role: Senior Manager, Clinical Operations, overseeing the planning, execution, and oversight of Phase I-IV clinical trials within a biopharma setting, supporting rare disease programs. Responsibilities: lead or support trial operational activities, including study start-up, monitoring, vendor oversight, and compliance; serve as Lead Clinical Trial Manager for assigned studies; ensure adherence to ICH-GCP, global regulations, and SOPs; collaborate cross-functionally with Clinical Development, Data Management, Regulatory, and other teams; manage budgets, timelines, and risk mitigation; oversee site feasibility, selection, and issue resolution; mentor junior staff and support inspection readiness. Requirements: Bachelor’s in a scientific discipline; 7+ years in clinical research within pharma, biotech, or CRO; deep knowledge of GCP, global trial regulations, and risk-based quality management; experience managing cross-functional teams and vendor relationships; proficiency in project management tools and Microsoft Office. Preferred: experience in rare diseases and global centers of excellence; familiarity with audit processes and inspection readiness frameworks; 20% travel expected. High-Value: managing late-stage (Phases I-IV) trials, vendor oversight, global regulatory compliance, and team leadership in a complex clinical trial environment. Work setup: not specified, but travel is approximately 20%.