Senior Director, Site Management and Monitoring Oversight
CSL
full-time
Posted on:
Location Type: Office
Location: Maidenhead • Massachusetts, Pennsylvania • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Provide executive leadership in the development, execution, and continuous optimization of global oversight frameworks, including Monitoring Oversight Visits and Compliance Oversight Programs.
- Oversee GCP compliance and data integrity across a global footprint of more than 1,300 clinical trial sites and over 31,000 participants.
- Drive strategic oversight of site management and monitoring activities across all phases of clinical development.
- Ensure CRO(s) maintain high-quality, inspection-ready operations and resolve site-level issues proactively.
- Lead governance and oversight of Clinical Research Organization (CRO) partnerships and act as strategic partner with CRO leadership.
- Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and CRO stakeholders to ensure inspection readiness and continuous improvement.
- Serve as the escalation lead for site-level quality and compliance issues, ensuring timely resolution and documentation.
- Lead a geographically dispersed team, develop internal talent, and oversee CRO capabilities to ensure consistent oversight.
- Champion oversight technologies, dashboards, and analytics to support proactive, risk-based monitoring and data-driven decision-making.
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.
- Experience leading geographically dispersed teams and overseeing CRO capabilities.
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.
- Inclusion and Belonging is at the core of our mission and who we are.
- Reasonable accommodation for applicants with disabilities during the application process.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GCP compliancedata integritysite managementmonitoring activitiesoversight strategiesrisk-based monitoringdata-driven decision-makingclinical operationsvendor oversightanalytics
Soft skills
leadershipcommunicationstakeholder engagementteam developmentproblem-solvingstrategic partnershipgovernancequality assurancecontinuous improvementescalation management