Risk and Central Monitoring Associate Manager

Accountabilities: Lead and oversee Risk-Based Quality Management (RBQM) activities for assigned clinical studies, ensuring alignment with study objectives and quality requirements. Develop, maintain, and coordinate approvals for Central Monitoring Plans that reflect study-specific risks and monitoring strategies. Support the development, assessment, and ongoing review of study risk assessments in collaboration with cross-functional teams. Facilitate the identification, tracking, evaluation, and monitoring of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs). Conduct centralized monitoring reviews to identify trends, data outliers, emerging signals, and potential risks that could affect study quality or integrity. Recommend appropriate follow-up actions and risk mitigation strategies based on monitoring findings and data-driven insights. Maintain central monitoring dashboards and support ongoing monitoring activities throughout the clinical trial lifecycle. Provide training, guidance, and practical support to study teams on RBQM principles, centralized monitoring approaches, and risk management processes. Contribute to inspection readiness by supporting documentation quality, monitoring records, and consistent implementation of established procedures. Participate in sponsor interactions, audits, project meetings, and other activities related to clinical study oversight. Maintain awareness of project budgets and contribute to effective resource and financial management within assigned responsibilities. Collaborate with global project teams and internal stakeholders to promote consistent monitoring practices and regulatory compliance. Support clinical studies in accordance with applicable ICH Good Clinical Practice (GCP) guidelines and relevant regulatory requirements. Requirements: Bachelor's degree in a relevant field, a registered nursing qualification (RN), or an equivalent combination of education, skills, and professional experience. At least four years of experience in clinical research, including a minimum of three years working with Risk-Based Monitoring (RBM) and associated ICH guidelines or regulatory guidance. Previous experience working as a Central Monitor or within a Central Monitoring function. Strong understanding of Risk-Based Quality Management (RBQM), study risk assessments, centralized monitoring processes, KRIs, and QTLs. Knowledge of clinical trial quality oversight and the application of risk-based approaches throughout the study lifecycle. Demonstrated ability to analyze complex clinical data, identify trends and anomalies, assess potential risks, and recommend appropriate actions. Strong critical-thinking and problem-solving skills, with the ability to investigate issues and support effective resolution. Experience collaborating across functional teams and contributing to global clinical research projects. Excellent communication and presentation skills, with the ability to explain monitoring findings and risk management strategies to diverse stakeholders. Strong planning, organizational, and time management skills, including the ability to coordinate multiple activities and priorities. Proficiency in English, with the ability to communicate effectively in an international working environment. Strong proficiency in Microsoft Office applications and familiarity with clinical research technology systems. Ability to work independently in a remote setting while maintaining effective collaboration across multiple teams and time zones. Benefits: Fully remote work arrangement for eligible candidates based in Brazil, with collaboration across international teams and time zones. Full-time employment opportunity. Competitive compensation based on relevant experience, education, performance, and internal equity. A competitive benefits package, with specific offerings depending on the candidate's location. Commitment to pay transparency, pay equity, and compliance with applicable employment laws. Opportunity to contribute to clinical research initiatives focused on improving patient outcomes and advancing medical knowledge. Collaborative, multidisciplinary working environment with opportunities to engage with clinical, scientific, and research professionals. Opportunities to develop expertise in risk-based quality management, centralized monitoring, and clinical trial oversight. Compensation note: The original posting lists an annual salary range of $65,500–$130,500 for the United States . This range is specific to US-based positions and should not be interpreted as the salary range for candidates based in Brazil. Brazilian compensation details are not specified in the original posting. Specific healthcare coverage, paid leave, retirement contributions, and other country-specific benefits are not detailed in the original job description.