Manager, Centralized, Risk-Based Monitoring & Risk-Based Quality Management (RBQM)

Location: Poland (Home-Based)
 

At Fortrea, we are advancing clinical trials through innovative, risk-based approaches and data-driven oversight. We are looking for an experiencedManager, Centralized & Risk-Based Monitoring& Risk-Based Quality Management (RBQM) to be part ofa high-performing team and drive centralized monitoring activities across global clinical studies.
 

What You'll Do

• Oversee site-, regional-, and study-level centralized and risk-based monitoring activities.
• Review and identify risks, trends, protocol deviations, and safety concerns, and ensure timely escalation and resolution.
• Partner with Clinical Trial Leads, CRAs, Project Managers, and sponsors to support effective study oversight.
• Drive study risk assessments, monitoring plans, analytics, dashboards, and data-driven monitoring strategies.
• Serve as a key customer contact for assigned studies and contribute to proposals, bid defenses, and sponsor presentations.
• Ensure compliance with ICH-GCP, regulatory requirements, and Fortrea SOPs while supporting continuous process improvement initiatives.
   

What We're Looking For

• Degree in Life Sciences, Nursing, Medical Technology, or a related healthcare discipline.
• Around 10–12 years of clinical research experience.
• At least 2 years of experience in Risk-Based Quality Management (RBQM) or Centralized Monitoring, Risk-Based Monitoring (RBM),
• Experience with RBQM analytical systems available in the market (e.g: Xcellerate, Cluepoints, Spotfire, client specific, etc).
• Strong knowledge of ICH-GCP and clinical trial regulations.
• Strong analytical, problem-solving, communication, and stakeholder management skills.
• Advanced MS Office skills.
• Fluent English.
   

Why Fortrea?

• Fully home-based role in Poland.
• Opportunity to lead global studies and influence risk-based monitoring strategies & Risk-Based Quality Management (RBQM) approach.
• Collaborative international environment and strong career development opportunities.
• Meaningful work that helps bring new therapies to patients worldwide.
   

Ready to make an impact? Apply today and help shape the future of clinical trial monitoring at Fortrea!

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