Manager, Centralized, Risk-Based Monitoring & Risk-Based Quality Management (RBQM)
On-siteWarsaw, Mazovia, Poland
Job Summary
Oversee site-, regional-, and study-level centralized and risk-based monitoring activities while reviewing risks, trends, protocol deviations, and safety concerns for timely escalation. Partner with Clinical Trial Leads, CRAs, Project Managers, and sponsors to support effective study oversight and drive risk assessments, monitoring plans, analytics, and dashboards. Serve as a key customer contact for assigned studies, contributing to proposals, bid defenses, and sponsor presentations while ensuring compliance with ICH-GCP and regulatory requirements. This fully home-based role in Poland supports continuous process improvement initiatives within a high-performing team driving global clinical study oversight.
Required Qualifications
- 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
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