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.