Fortrea
Sr. Manager, Centralized Monitoring, Risk-Based Monitoring (RBM) & Risk-Based Quality Management (RBQM)
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Lead and oversee centralized and risk-based monitoring activities across global clinical studies. Identify risks, trends, and safety concerns, drive risk assessments, monitoring plans, analytics, dashboards, and data-driven strategies. Partner with study teams and sponsors, ensure ICH-GCP and regulatory compliance, and support continuous process improvements and sponsor-facing activities.
Sr. Manager, Centralized Monitoring, Risk-Based Monitoring (RBM) & Risk-Based Quality Management (RBQM) – Latin America
At Fortrea, we are advancing clinical trials through innovative, risk-based approaches and data-driven oversight. We are looking for an experienced Sr. Manager, Centralized Monitoring, Risk-Based Monitoring (RBM) & 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 monitoring and risk-based monitoring activities.
- Review and identify risks, trends, protocol deviations, and safety concerns, ensuring 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.
- Degree in Life Sciences, Nursing, Medical Technology, or a related healthcare discipline.
- Approximately 10–12 years of clinical research experience.
- At least 2 years of experience in Risk-Based Quality Management (RBQM), Centralized Monitoring, or Risk-Based Monitoring (RBM).
- Experience with RBQM analytical systems available in the market (e.g., Xcellerate, CluePoints, Spotfire, sponsor-specific platforms, 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.
- Fully home-based role in Latin America.
- Opportunity to lead global studies and influence centralized monitoring, risk-based monitoring, and RBQM strategies.
- Collaborative international environment and strong career development opportunities.
- Meaningful work that helps bring new therapies to patients worldwide.
Candidates must be based in Latin America and have authorization to work in their country of residence.
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.
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