Manager, Risk Based Quality Management

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, Risk Based Quality Management based in United States.

This role supports the execution and continuous improvement of risk-based quality management across a clinical trial portfolio. You will help coordinate quality and risk planning activities, facilitate cross-functional risk reviews, and ensure follow-up actions are clearly documented and completed. Working closely with Clinical Project Management, Data Management, Quality, Medical Monitoring, Biostatistics, and other teams, you will help identify and proactively address risks that could affect trial quality. The position combines clinical research knowledge, operational coordination, data review, and quality oversight in a collaborative environment. You will also contribute to centralized monitoring activities and the effective use of RBQM technologies and documentation systems. This is an opportunity to develop expertise in modern clinical trial quality management while contributing to processes that support the delivery of important therapies.

Accountabilities:

• Coordinate the development, maintenance, and operational execution of Integrated Quality and Risk Management Plans (IQRMPs) across clinical studies.
• Support RACT, Risk Management Plan (RMP), and Issue Detection and Resolution Plan (IDRP) activities, including protocol review and risk assessment.
• Facilitate cross-functional risk review meetings, document outcomes, and track action items through to completion.
• Maintain RBQM documentation, trackers, logs, templates, SharePoint resources, and other governance materials to support consistent execution.
• Coordinate study-specific RBQM activities and promote accountability across clinical trial teams.
• Support routine centralized monitoring activities, including KRI and QTL review, preparation of risk reviews, and follow-up discussions.
• Collaborate with Clinical Project Management, Data Management, Quality, Medical Monitoring, Biostatistics, and other functional teams to support effective RBQM implementation.
• Assist RBQM leadership with strategic, operational, and client-facing initiatives related to quality and risk management.
• Use RBQM platforms and clinical trial systems, including business intelligence tools, CluePoints, Medidata, and related technologies, to support monitoring and documentation.
• Contribute to continuous improvement initiatives focused on RBQM processes, tools, documentation, and operational effectiveness.

Requirements

• Bachelor’s degree in health sciences, life sciences, or a related discipline, or an equivalent combination of education and relevant experience.
• At least 2 years of experience in clinical research, data management, clinical monitoring, quality, or a related function within a CRO, pharmaceutical, healthcare, or similar environment.
• Basic understanding of clinical trial operations and Good Clinical Practice (GCP) principles.
• Familiarity with risk-based quality management concepts, including Key Risk Indicators (KRIs), risk assessments, and centralized monitoring.
• Familiarity with ICH E6(R2/R3) guidelines and their application to clinical research quality.
• Experience reviewing clinical data, reports, study metrics, or other information used to assess trial quality is preferred.
• Experience with clinical trial systems such as EDC platforms and RBQM technologies such as CluePoints or Medidata is advantageous.
• Prior experience supporting risk review processes, data review, quality oversight, or related clinical trial governance activities.
• Strong organizational and coordination skills, with the ability to manage documentation, follow-ups, timelines, and multiple stakeholders.
• Effective communication and collaboration skills, with the ability to work across multidisciplinary clinical research teams.
• Analytical and detail-oriented approach with the ability to identify potential risks, follow established processes, and support continuous improvement.

Benefits

• Career development opportunities through structured mentoring and leadership development programs.
• Ongoing education and professional training opportunities, including tuition reimbursement and access to dedicated training resources.
• Hybrid work-from-home flexibility.
• Generous health benefits and vacation packages.
• Paid parental leave.
• Supportive work-life balance and a collaborative international work environment.
• Opportunities to contribute to clinical research supporting the development of treatments for chronically and critically ill patient populations.
• Exposure to global clinical trial operations and cross-functional quality and risk management.
• Opportunities to develop expertise in RBQM methodologies, centralized monitoring, clinical trial technologies, and quality oversight.