Risk Manager, Centralized Monitoring

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Risk/Centralized Monitoring Manager – Make an Impact at the Forefront of Innovation Locations: UK/Bulgaria/open to all EMEA locations Employment Type: Permanent Remote/Hybrid available We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. Risk Manager The Risk Manager is responsible for leading the implementation and execution of Risk-Based Quality Management (RBQM) strategies across assigned clinical studies. This role serves as the primary risk management lead, partnering with cross-functional study teams and clients to proactively identify, assess, monitor, and mitigate risks that may impact patient safety, data integrity, regulatory compliance, and study quality. The Risk Manager provides strategic oversight of risk management activities, drives operational excellence, and acts as a subject matter expert in RBQM methodology. Key Responsibilities Risk Management Strategy & Study Oversight Lead the development, facilitation, and maintenance of study risk assessments, ensuring alignment with ICH E6(R3), RBQM principles, and Thermo Fisher quality standards. Facilitate cross-functional risk assessment workshops to identify Critical-to-Quality (CtQ) factors, study risks, controls, and mitigation strategies throughout the clinical trial lifecycle. Review study protocols, monitoring plans, Central Monitoring Plans (CMPs), and other key study documents to ensure risks are appropriately identified, assessed, and mitigated. Continuously evaluate the effectiveness of risk controls and mitigation strategies through ongoing risk reviews, data analysis, and centralized monitoring outputs. Lead periodic risk review meetings with study teams, documenting outcomes, action plans, and escalating significant risks when appropriate. Partner with Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Pharmacovigilance, and other functional areas to integrate risk management into study execution. Represent the Risk Management function during study startup activities, including project launch meetings, Kick-Off Meetings (KOMs) Collaborate with project leadership to develop study-specific RBQM strategies that align with protocol requirements and client expectations. Coordinate risk management deliverables and timelines to support successful study startup and execution. Monitor the execution of risk management activities to ensure delivery within quality, timeline, and budget expectations. Escalate emerging risks, quality concerns, and operational issues to project leadership as appropriate. Serve as the primary RBQM subject matter expert for assigned studies and provide consultation to study teams on risk management best practices. Develop strong partnerships with internal functional teams and clients to promote proactive risk management and quality-focused decision making. Represent the Risk Management function during client meetings, governance meetings, audits, inspections, and business development activities as needed. Utilize centralized monitoring outputs, Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and data analytics to identify emerging risks and support risk-based decision making. Interpret data trends and quality signals to evaluate study performance and recommend appropriate actions. Contribute to departmental initiatives related to process improvement, quality enhancement, RBQM methodology, analytics, and technology development. Support the development, implementation, and maintenance of RBQM standards, procedures, guidance documents, and training materials. Provide guidance and expertise to study teams on RBQM processes, risk assessment methodology, and the application of risk management tools to support consistent execution across studies. Qualifications Bachelor's degree in Life Sciences, Nursing, Pharmacy, Biostatistics, Data Science, or related field (advanced degree preferred). Significant experience in clinical research, Clinical Operations, Central Monitoring, Risk-Based Quality Management (RBQM), or Data Analytics within a CRO or pharmaceutical environment. Strong knowledge of ICH E6(R3), ICH E8(R1), FDA, EMA, and global regulatory requirements related to RBQM. Experience facilitating risk assessments and developing Critical-to-Quality (CtQ) frameworks, knowledge of Key Risk Indicators (KRIs), and Quality Tolerance Limits (QTLs). Strong analytical, communication, facilitation, and stakeholder management skills. Experience working directly with sponsors and cross-functional global study teams. Demonstrated ability to manage multiple priorities in a fast-paced global environment while driving quality and operational excellence. Working Conditions and Environment: • Work is performed in an office environment with exposure to electrical office equipment. • Occasional drives to site locations with occasional travel both domestic and international. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs.