Clinical Data Risk Manager

Accountabilities

• Implement and coordinate RBQM procedures for assigned clinical studies, including initial and recurring risk identification, assessment, centralized monitoring, and mitigation.
• Review study protocols and facilitate the development of Study Risk Assessments, defining critical data, critical processes, Key Risk Indicators (KRIs), and Quality Tolerance Limits (QTLs) in collaboration with study teams.
• Develop study-specific RBQM materials, lead training sessions and kick-off meetings, and author and implement study-specific RBQM plans.
• Lead cross-functional risk assessment meetings to identify Critical-to-Quality (CtQ) risks throughout the clinical trial lifecycle.
• Partner with RBQM system configuration teams to ensure risk indicators, QTLs, analytics, and visualizations are configured and functioning according to operational requirements.
• Conduct periodic centralized monitoring of aggregate study data at study, regional, country, site, and patient levels to identify emerging risks and issues.
• Lead risk review discussions, communicate monitoring findings, facilitate root cause analysis, and develop appropriate mitigation strategies with study teams.
• Ensure corrective and preventive actions (CAPAs) are documented, assigned, implemented, and monitored for effectiveness; recommend adjustments when risk signals persist or change.
• Prepare signal and trend reports to help study teams interpret RBQM outputs and make informed decisions.
• Collaborate with Adaptive Monitoring Excellence teams on signals that may require adjustments to targeted Source Data Verification (SDV) and Source Data Review (SDR) plans.
• Maintain accurate and up-to-date RBQM documentation, support internal and external audits and inspections, and contribute to regulatory interactions related to RBQM adoption.
• Maintain consistency, quality, and compliance with RBQM procedures across studies, adapting plans based on feedback and data-driven trends.
• Share best practices, lessons learned, case studies, and process improvement opportunities to strengthen RBQM methodology and consistency.
• Act as an RBQM subject matter expert and change champion, guiding study teams in adopting effective practices and maximizing the value of the framework.
• Provide line management and supervision to junior RBQM Operations staff when required.

Requirements

• Bachelor's degree in a health-related or life sciences discipline, or an international equivalent, preferred; an equivalent combination of education, training, and professional experience may also be considered.
• At least 6 years of experience in the pharmaceutical or Contract Research Organization (CRO) industry.
• At least 2 years of experience in Risk-Based Quality Management (RBQM).
• At least 2 years of managerial or supervisory experience.
• Strong understanding of the drug development process and clinical trial execution.
• Knowledge of relevant regulatory standards and guidelines, including 21 CFR Part 11, ICH E6, and ICH E8 (GCP).
• Practical experience in risk management, sponsor audits, health authority inspections, root cause analysis, risk mitigation, and Corrective and Preventive Actions (CAPAs).
• Familiarity with RBQM platforms, clinical systems, or other data analytics tools.
• Strong analytical skills, including the ability to interpret complex data, identify patterns and trends, and recommend improvements.
• Demonstrated ability to lead cross-functional meetings, build effective collaborations, and influence stakeholders without relying on formal authority.
• Excellent communication, interpersonal, organizational, and problem-solving skills, with the ability to engage effectively across functions and seniority levels.
• A pragmatic, adaptable, and collaborative approach to change, with comfort working in ambiguous environments.
• Critical thinking, attention to detail, creative problem-solving, and a willingness to challenge existing approaches.
• Commitment to continuous improvement, innovation, knowledge sharing, and inclusive teamwork.

Benefits

• Competitive base salary and performance-related incentives.
• Medical, dental, and vision coverage, where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Structured learning and development opportunities, including training and career pathways.
• Remote working arrangement.
• Benefits and coverage may vary depending on the role and location.

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