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Director à Grande-Bretagne

Senior Director Head of Site Management and Monitoring Oversight

CSL Plasma

Maidenhead
Sur place
GBP 90 000 - 120 000
Il y a 7 jours
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Senior Director Head of Site Management and Monitoring Oversight
CSL Plasma
Maidenhead
Sur place
GBP 90 000 - 120 000
Plein temps
Il y a 8 jours

Résumé du poste

A leading global biotherapeutics firm in Maidenhead is seeking a Head of Site Management and Monitoring. This senior leadership role is responsible for strategic oversight and operational excellence in clinical trial execution. The ideal candidate will have over 12 years of experience in clinical operations, particularly in site monitoring, and a strong understanding of regulatory standards. This position offers the chance to foster a culture of agility and accountability within a dynamic team environment.

Prestations

Well-being programs
Innovative work environment

Qualifications

  • 12+ years of experience in clinical operations with a focus on site monitoring.
  • Proven track record in managing global teams and oversight strategies.
  • Deep understanding of ICH-GCP and regulatory frameworks.

Responsabilités

  • Provide strategic oversight and quality governance for global site monitoring.
  • Drive operational excellence aligned with regulatory requirements.
  • Lead governance of Clinical Research Organization partnerships.

Connaissances

Leadership in clinical operations
Communication skills
Analytical skills
Stakeholder engagement

Formation

Undergraduate degree in life sciences
Advanced degrees preferred
Description du poste

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.

TheHead of Site Management and Monitoringis 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.

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.

Leadership and Capability Development: 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. Drive innovation to meet the demands of large-scale, global clinical operations and deliver continual process optimization

Qualifications & Experience Requirements
  • 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

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

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. 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, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

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. 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. Learn more about inclusion and belonging at CSL.

Do work that matters at CSL Behring!

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* Le salaire de référence se base sur les salaires cibles des leaders du marché dans leurs secteurs correspondants. Il vise à servir de guide pour aider les membres Premium à évaluer les postes vacants et contribuer aux négociations salariales. Le salaire de référence n’est pas fourni directement par l’entreprise et peut pourrait être beaucoup plus élevé ou plus bas.

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