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.
Local
São Paulo - SP
Remoto
Responsabilidades
- 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.
Requisitos
- 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.
Benefícios
- 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.
Sobre a empresa
This position is listed on behalf of a partner company, who manages all applications and next steps.
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