Manager, Centralized, Risk-Based Monitoring & Risk-Based Quality Management (RBQM)
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AI Summary
Oversee site, regional, and study-level centralized and risk-based monitoring activities to identify risks and ensure timely resolution. Partner with clinical leads and sponsors to drive risk assessments, analytics, and compliance with regulatory requirements.
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 experienced Manager, Centralized & Risk-Based Monitoring & Risk-Based Quality Management (RBQM) to be part of a 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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