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Urgent! Senior Director Head of Site Management and Monitoring Oversight Job Opening In Waltham – Now Hiring CSL
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.
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.
✨ Smart • Intelligent • Private • Secure
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Unlock Your Senior Director Potential: Insight & Career Growth Guide
Real-time Senior Director Jobs Trends in Waltham, United States (Graphical Representation)
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Great news! CSL is currently hiring and seeking a Senior Director Head of Site Management and Monitoring Oversight to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at CSL adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Senior Director Head of Site Management and Monitoring Oversight Jobs United States varies, but the pay scale is rated "Standard" in Waltham. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Senior Director Head of Site Management and Monitoring Oversight typically include Other Management Occupations and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Before the Interview:To prepare for your Senior Director Head of Site Management and Monitoring Oversight interview at CSL, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the CSL's products or services and be prepared to discuss how you can contribute to their success.
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