Risk and Central Monitoring Associate Manager

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Risk and Central Monitoring Associate Manager based in United States . Join a global clinical research environment dedicated to advancing medical innovation and improving patient outcomes. In this role, you will help strengthen clinical trial quality by leading risk-based quality management (RBQM) activities and supporting centralized monitoring strategies across assigned studies. You will collaborate with multidisciplinary teams and sponsors to identify potential risks, evaluate clinical data, and develop proactive mitigation approaches. Through the use of key risk indicators, quality tolerance limits, and monitoring dashboards, you will help teams make informed, data-driven decisions throughout the clinical trial lifecycle. You will also contribute to regulatory compliance, inspection readiness, and consistent quality standards aligned with ICH Good Clinical Practice guidelines. This remote opportunity offers the chance to work with international teams and make a meaningful contribution to reliable, high-quality clinical research. 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.