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.