Associate Director, Site Monitoring

Objective / Purpose

Provide leadership and oversight of site monitoring activities across assigned clinical studies or regions to ensure delivery in line with quality, timelines, and budget. Drive execution of Takeda’s site monitoring strategy, including Risk-Based Monitoring (RBM/RBQM) approaches and internalized monitoring capabilities. Ensure compliance with ICH-GCP, local regulatory requirements, and Takeda SOPs across all site monitoring activities. Lead and develop a high-performing team and/or oversee FSP and CRO site monitoring performance to support efficient clinical trial delivery.

Accountabilities

Site Monitoring Oversight & Delivery

• Oversee compliance and quality of the planning and execution of site monitoring activities including Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, Close-Out Visits, and Monitoring Oversight Visits.
• Ensure study-specific site monitoring plans are developed, approved, and executed using Takeda standards and systems.
• Provide oversight of CRO-delivered site monitoring activities, ensuring quality, compliance, and performance expectations are met.
• Assess trends in site monitoring visit conduct, reporting, issues, and corrective actions.

Operational Leadership

• Serve as functional leader for site monitoring within assigned programs, ensuring alignment with study teams and cross-functional stakeholders.
• Act as escalation point for site-related and site monitoring issues, ensuring timely resolution and risk mitigation.
• Contribute to study start-up, execution, and close-out phases through strategic input and operational oversight of site monitoring.
• Drive consistent execution of RBQM principles and continuous improvement in site monitoring.

People Leadership & Development

• Provide line management and/or functional oversight of Site Monitors and Site Monitoring Leads.
• Ensure appropriate training, onboarding, and ongoing development of team members to maintain high-quality site monitoring standards.
• Foster a culture of accountability, collaboration, and continuous improvement across the site monitoring organization.
• Support talent development, succession planning, and performance management.

Quality, Compliance & Inspection Readiness

• Ensure adherence to all applicable regulatory requirements, Takeda SOPs, and quality standards.
• Maintain inspection readiness of site monitoring processes and deliverables at all times, supporting audits and regulatory inspections.
• Ensure accurate use of and documentation in TMF, CTMS, and EDC systems.

Stakeholder Collaboration

• Partner with Clinical Study Management, Clinical Study Site Engagement, Data Management, and other cross-functional teams to ensure seamless study execution.
• Act as subject matter expert for site monitoring in cross-functional initiatives, stakeholder engagements, and process improvements.
• Provide input into resource planning and budget forecasting for site monitoring activities.

Process Improvement & Innovation

• Lead or contribute to initiatives to optimize monitoring processes, tools, and technologies.
• Promote best practices, lessons learned, and continuous improvement across studies and programs.

Education & Competencies (Technical and Behavioral)

• Bachelor’s Degree or international equivalent required, Life Sciences preferred. Advanced degree highly desirable.
• 8+ years of CRA / clinical site monitoring or site monitoring line/functional management experience within the biotech/pharma/CRO industry.
• Global/international team experience preferred, including ability to collaborate with colleagues and staff in other locations.
• Strong understanding of ICH/GCP and associated regulations.
• Experience with risk-based monitoring models and clinical systems including CTMS, EDC, eTMF, and eCOA.
• Proven track record of leading a site monitoring team and driving quality execution.
• Track record of successful leadership, management, and development of large site monitoring teams.