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Job Description
Objective / Purpose:
- Provide leadership and oversight of site monitoring activities across assigned clinical studies 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 CRO site monitoring performance to support efficient clinical trial delivery.
Accountabilities:
Site Monitoring Oversight & Delivery
- Oversee 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:
- Bachelor’s Degree or international equivalent required, Life Sciences preferred. Advanced degree highly desirable.
- 8+ years of CRA or clinical site monitoring experience within the biotech/pharma/CRO industry.
- Global/international experience required, 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.
Locations
Lodz, Poland
Base Salary Range:
zł350,200.00 - zł481,580.00
For information about our benefits, please click here.
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
