Senior Director Head of Site Management and Monitoring Oversight

CSL Behring; Reading; On-site; GBP 90,000 - 120,000; Full time

Job summary

A global biotherapeutics leader is seeking a Head of Site Management and Monitoring in Reading, UK. This senior leadership role involves overseeing global site monitoring activities and ensuring regulatory compliance in clinical trials. Ideal candidates have over 12 years of experience in clinical operations, strong leadership skills, and an understanding of ICH-GCP. The company is dedicated to innovation in patient care and fostering inclusion within its workforce.

Qualifications

• 12+ years of experience in clinical operations, especially in site monitoring.
• Proven leadership in managing global teams and vendor oversight.
• Strong understanding of ICH-GCP and regulatory frameworks.

Responsibilities

• Oversee global site monitoring activities across all clinical development phases.
• Ensure CRO operations are inspection-ready and high-quality.
• Drive accountability and resolve quality issues with CRO partners.

Skills

Leadership

Compliance oversight

Stakeholder engagement

Analytical skills

Education

Undergraduate degree in life sciences or health/medical-related field

Advanced degrees preferred

Job description

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.

Roles & Responsibilities

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.

Qualifications

• Minimum undergraduate degree in life sciences or health/medical-related field; advanced degrees preferred.
• 12+ years of experience in clinical operations, with a strong background in site monitoring and vendor oversight.
• Proven leadership in managing global teams and implementing oversight strategies for site operations.
• Deep understanding of ICH-GCP, regulatory frameworks, and best practices in sponsor oversight.
• Strong analytical, communication, and stakeholder engagement skills

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.

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

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. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.