Sr. Manager, Centralized Monitoring, Risk-Based Monitoring (RBM) & Risk-Based Quality Management (RBQM) in Brazil, Indiana at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Manager, Centralized Monitoring, Risk-Based Monitoring (RBM) & Risk-Based Quality Management (RBQM) based in Brazil.

This is a strategic leadership opportunity for an experienced clinical research professional specializing in centralized monitoring and risk-based quality management. In this role, you will drive data-driven oversight strategies that improve clinical trial quality, identify risks early, and support successful global study execution. You will collaborate with clinical operations teams, sponsors, and cross-functional stakeholders to design and implement effective monitoring approaches. The position combines scientific expertise, analytical thinking, and stakeholder management within a collaborative international environment. You will play a key role in advancing innovative clinical trial methodologies while ensuring compliance with regulatory standards and quality expectations. This fully remote opportunity is ideal for professionals passionate about improving patient outcomes through smarter, risk-based approaches to clinical research.

• Lead centralized monitoring, risk-based monitoring (RBM), and risk-based quality management (RBQM) activities across clinical studies at site, regional, and study levels.
• Review study data, identify emerging risks, trends, protocol deviations, and potential safety concerns, and ensure timely escalation and resolution.
• Develop and support risk assessments, monitoring strategies, analytics, dashboards, and data-driven oversight plans.
• Partner with Clinical Trial Leads, Clinical Research Associates, Project Managers, sponsors, and other stakeholders to strengthen study oversight and execution.
• Serve as a key point of contact for assigned studies, supporting client interactions, proposals, bid defenses, and sponsor presentations.
• Ensure clinical monitoring activities comply with ICH-GCP guidelines, regulatory requirements, internal procedures, and quality standards.
• Contribute to continuous improvement initiatives by identifying opportunities to optimize monitoring processes and operational effectiveness.
• Provide expertise and guidance on RBQM methodologies, centralized monitoring tools, and risk mitigation strategies.

• Bachelor’s degree in Life Sciences, Nursing, Medical Technology, or another related healthcare discipline.
• Approximately 10–12 years of experience in clinical research, with significant experience supporting clinical trial operations.
• Minimum of 2 years of hands-on experience in Risk-Based Quality Management (RBQM), Centralized Monitoring, or Risk-Based Monitoring (RBM).
• Experience using RBQM analytical platforms and monitoring technologies such as Xcellerate, CluePoints, Spotfire, sponsor-specific systems, or similar solutions.
• Strong understanding of ICH-GCP principles, clinical trial regulations, and quality management practices.
• Advanced analytical and problem-solving skills with the ability to interpret complex clinical data and identify potential risks.
• Excellent communication, collaboration, and stakeholder management abilities across global teams.
• Strong organizational skills with the ability to manage multiple priorities in a dynamic environment.
• Advanced proficiency with Microsoft Office tools.
• Fluent English communication skills required.
• Must be based in Brazil with authorization to work in the country of residence.

• Fully remote, home-based position in Brazil.
• Opportunity to lead global clinical studies and influence advanced monitoring and quality management strategies.
• Work with international teams in a collaborative and innovative clinical research environment.
• Meaningful opportunity to contribute to the development of therapies that improve patient outcomes.
• Career development opportunities within a global healthcare and clinical research organization.
• Exposure to advanced technologies, analytics, and data-driven approaches in clinical trial oversight.