Senior Manager, Centralized Monitoring, Risk-Based Monitoring (RBM), Risk-Based Quality Management (RBQM)

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• 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.

🎯 Requirements

• 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. • Advanced MS Office skills. • Fluent English.

🏖️ Benefits

• Fully home-based role in Latin America • Collaborative international environment and strong career development opportunities • Meaningful work that helps bring new therapies to patients worldwide