Associate Director, Site Monitoring
About The Position
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 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. The role oversees the quality and compliance of site monitoring planning and execution, including Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, Close-Out Visits, and Monitoring Oversight Visits. It ensures study-specific monitoring plans are developed, approved, and executed using Takeda standards and systems; monitors CRO performance; and assesses trends in visit conduct, reporting, issues, and corrective actions. As the functional leader for site monitoring within assigned programs, the Associate Director aligns with study teams and cross-functional stakeholders, serves as an escalation point for site-related issues, and contributes strategic and operational oversight through study start-up, execution, and close-out. The position drives consistent RBQM implementation and continuous improvement. The role provides line management and/or functional oversight of Site Monitors and Site Monitoring Leads, including training, onboarding, development, talent development, succession planning, and performance management. It fosters accountability, collaboration, and continuous improvement. The Associate Director ensures adherence to regulatory requirements, Takeda SOPs, and quality standards; maintains inspection readiness; and ensures accurate documentation in TMF, CTMS, and EDC systems. The role partners with Clinical Study Management, Clinical Study Site Engagement, Data Management, and other teams; acts as a site monitoring subject matter expert; and contributes to resource planning, budget forecasting, process optimization, and the sharing of best practices and lessons learned.
Requirements
- Bachelor’s degree or international equivalent required; Life Sciences preferred.
- At least 8 years of CRA, clinical site monitoring, or site monitoring line/functional management experience within the biotech, pharmaceutical, or CRO industry.
- 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.
Nice To Haves
- Advanced degree highly desirable.
- Global/international team experience preferred, including the ability to collaborate with colleagues and staff in other locations.
Responsibilities
- Oversee the quality and compliance of site monitoring planning and execution, 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.
- Oversee CRO-delivered site monitoring activities and ensure quality, compliance, and performance expectations are met.
- Assess trends in site monitoring visit conduct, reporting, issues, and corrective actions.
- Serve as functional leader for site monitoring within assigned programs and align activities with study teams and cross-functional stakeholders.
- Act as an escalation point for site-related and site monitoring issues, ensuring timely resolution and risk mitigation.
- Contribute strategic input and operational oversight during study start-up, execution, and close-out.
- Drive consistent execution of RBQM principles and continuous improvement in site monitoring.
- Provide line management and/or functional oversight of Site Monitors and Site Monitoring Leads.
- Ensure appropriate training, onboarding, and ongoing development of team members.
- Support talent development, succession planning, and performance management.
- Ensure adherence to applicable regulatory requirements, Takeda SOPs, and quality standards.
- Maintain inspection readiness of site monitoring processes and deliverables, supporting audits and regulatory inspections.
- Ensure accurate use of and documentation in TMF, CTMS, and EDC systems.
- Partner with Clinical Study Management, Clinical Study Site Engagement, Data Management, and other cross-functional teams.
- Act as a site monitoring subject matter expert in cross-functional initiatives, stakeholder engagements, and process improvements.
- Provide input into resource planning and budget forecasting for site monitoring activities.
- Lead or contribute to initiatives to optimize monitoring processes, tools, and technologies.
- Promote best practices, lessons learned, and continuous improvement across studies and programs.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
