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

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Manage centralized monitoring and risk-based monitoring activities at the site, regional, and study levels.

• Analyze and pinpoint risks, trends, protocol deviations, and safety issues, ensuring prompt escalation and resolution.

• Collaborate with Clinical Trial Leads, CRAs, Project Managers, and sponsors to facilitate effective study oversight.

• Lead the development of study risk assessments, monitoring plans, analytics, dashboards, and data-driven monitoring methodologies.

• Act as a primary contact for assigned studies and assist in the preparation of proposals, bid defenses, and sponsor presentations.

• Ensure adherence to ICH-GCP, regulatory standards, and Fortrea SOPs while fostering initiatives for continuous process enhancement.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Nursing, Medical Technology, or a similar healthcare field.

• Approximately 10–12 years of experience in clinical research.

• A minimum of 2 years of involvement in Risk-Based Quality Management (RBQM), Centralized Monitoring, or Risk-Based Monitoring (RBM).

• Familiarity with RBQM analytical systems available in the market (e.g., Xcellerate, CluePoints, Spotfire, sponsor-specific platforms, etc.).

• Comprehensive understanding of ICH-GCP and clinical trial regulations.

• Proficient in MS Office applications.

• Fluent in English.

🏝️ Benefits

• Fully remote position based in Latin America.

• Collaborative international environment with robust career advancement opportunities.

• Engaging work that contributes to delivering new therapies to patients globally.