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 general 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.
What We’re Looking For
- 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 Eng
📌 Sr. Manager, Centralized Monitoring, Risk-Based Monitoring (RBM) & Risk-Based Quality Managemen[...] (Lima)
🏢 Fortrea
📍 Lima