CSL seeks a Senior Manager, Clinical Operations to lead the planning and execution of global clinical trials across our biotherapies and vaccine portfolio. In this role, you will oversee study start up through closeout, including site selection, patient enrollment, and vendor/CRO management, while ensuring adherence to ICH GCP, FDA, and global regulations. You will provide strategic operational input to protocols and budgets, drive risk management and inspection readiness, and guide a high performing clinical operations team. Collaborating closely with Clinical Development, Regulatory, and other functions, you will help deliver high quality data that advances life saving therapies for patients worldwide. Responsibilities Lead regional clinical operations for CSL's biotherapy and vaccine trials from study start-up through closeout Oversee site selection, feasibility, and activation to ensure timely patient enrollment and retention Manage CROs and clinical vendors, ensuring adherence to timelines, budgets, and quality standards Ensure compliance with GCP, ICH, FDA and global regulatory requirements and CSL SOPs Develop and optimize clinical operational plans, risk mitigation strategies, and performance metrics Provide leadership, coaching, and development to clinical operations staff and cross functional study teams Collaborate with Clinical Development, Regulatory, Biostatistics, and Medical Affairs to deliver study milestones Drive inspection readiness, audit responses, and continuous process improvement across clinical operations Contribute operational input to protocol design, study budgets, and outsourcing strategies Communicate trial status, risks, and decisions to senior leadership and key stakeholders Required Skills Clinical trial management ICH-GCP and FDA/global regulatory knowledge Vendor and CRO management Clinical operations strategy and planning Risk management and mitigation Budgeting and financial oversight for trials People leadership and team development Inspection readiness and audit management Clinical study start-up and site management Data quality and compliance oversight