Takeda
Pharma
AssociateDirector,SiteMonitoring
“Associate Director, Site Monitoring at Takeda. Skills: Site monitoring oversight, Clinical trial execution, Team leadership. Provide leadership and oversight of site monitoring activities. Ensure delivery in line with quality, timelines, and”
What You'll Achieve.
Ensure delivery in line with quality; Ensure delivery in line with timelines; Ensure delivery in line with budget; Maintain inspection readiness at all times
Industry & Context.
Risk mitigation; Issue resolution
What They're Looking For.
Must Have
Bachelor's Degree or international equivalent, 8+ years CRA or clinical site monitoring experience, Global/international experience required, Strong understanding of ICH/GCP, Experience with risk-based monitoring models, Experience with CTMS, EDC, eTMF, and eCOA, Proven track record of leading a site monitoring team, Track record of successful leadership, management, and development of large site monitoring teams
Nice to Have
Advanced degree highly desirable, Life Sciences preferred
What You'll Do.
Provide leadership and oversight of site monitoring activities
Ensure delivery in line with quality
Drive execution of Takeda’s site monitoring strategy
Ensure compliance with ICH-GCP
local regulatory requirements
Lead and develop a high-performing team
Oversee CRO site monitoring performance
Oversee planning and execution of site monitoring activities
Ensure study-specific site monitoring plans are developed
Provide oversight of CRO-delivered site monitoring activities
Assess trends in site monitoring visit conduct
Serve as functional leader for site monitoring
Ensure alignment with study teams and cross-functional stakeholders
Act as escalation point for site-related and site
Ensure timely resolution and risk mitigation
Contribute to study start-up
Drive consistent execution of RBQM principles
Drive continuous improvement in site monitoring
Provide line management and/or functional oversight of Site
Ensure appropriate training
and ongoing development of
Foster a culture of accountability
Support talent development
and performance management
Ensure adherence to all applicable regulatory requirements
Maintain inspection readiness of site monitoring processes and
Support audits and regulatory inspections
Ensure accurate use of and documentation in TMF
Partner with Clinical Study Management
Partner with Clinical Study Site Engagement
Partner with Data Management
Partner with other cross-functional teams
Act as subject matter expert for site monitoring
Provide input into resource planning
Provide input into budget forecasting
Lead or contribute to initiatives to optimize monitoring
Lead or contribute to initiatives to optimize monitoring
Lead or contribute to initiatives to optimize monitoring
Promote best practices across studies and programs
Promote lessons learned across studies and programs
Promote continuous improvement across studies and programs
How You'll Work.
Team & Collaboration
Study teams; Cross-functional stakeholders; Clinical Study Management; Clinical Study Site Engagement; Data Management
Process & Methodology
Clinical trial delivery, Resource planning, Budget forecasting
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