DIRECTOR, HEAD OF

New Today

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Head of Site Management and Monitoring is a senior leadership role accountable for the strategic direction, operational execution, and quality oversight of global site monitoring activities across all phases of clinical development. This role is pivotal in ensuring that clinical trial execution meets regulatory, ethical, and scientific standards while enabling operational excellence in a highly outsourced environment.
Strategic Oversight and Quality Governance: ​
Provide executive leadership in the development, execution, and continuous optimization of global oversight frameworks, including Monitoring Oversight Visits, Compliance Oversight Programs, and site-level risk mitigation strategies. Oversee GCP compliance and data integrity across a global footprint of more than 1,300 clinical trial sites and over 31,000 participants, ensuring alignment with enterprise risk and quality objectives.​ Operational Excellence in Monitoring: ​
Drive strategic oversight of site management and monitoring activities across all phases of clinical development. Ensure global execution is fully aligned with protocol-specific risk assessments, regulatory requirements, and development timelines. Ensure the CRO(s) maintain high-quality, inspection-ready operations while proactively identifying and resolving site-level issues in a dynamic environment.​
CRO and FSP Governance: ​
Lead governance of and oversight of Clinical Research Organization (CRO) partnerships. Act as a key strategic partner and influencer with CRO leadership, building strong relationships to drive accountability, resolve quality and performance issues—often on a daily basis given the operational scale—and ensure delivery to protocol and regulatory expectations.​
Cross-Functional Leadership and Regulatory Readiness: ​
Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and CRO stakeholders to ensure global site performance, inspection readiness, and continuous improvement. Serve as the escalation lead for site-level quality and compliance issues, ensuring timely resolution, documentation, and alignment with regulatory standards and internal SOPs.​
Lead a geographically dispersed team, fostering a culture of agility, accountability, and performance. Develop internal talent and oversee CRO capabilities to ensure consistent, high-quality oversight across a complex and evolving clinical operations landscape.​
Innovation and Risk-Based Monitoring Enablement: ​
Champion the advancement of oversight technologies, dashboards, and analytics to support proactive, risk-based monitoring and data-driven decision-making. Minimum undergraduate degree in life sciences or health/medical-related field; 12+ years of experience in clinical operations, with a strong background in site monitoring and vendor oversight.​
~ Deep understanding of ICH-GCP, regulatory frameworks, and best practices in sponsor oversight.​
~ We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, . We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out.
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Location:
Maidenhead, Berkshire
Job Type:
FullTime

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