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!
Learn more about our EEO & Accommodations request here.
