Central Risk Manager – Risk Based Central Monitoring

• Advise on development and updates to project monitoring strategies based on risks
• Work with cross-functional leads to understand complex indications and risks and develop risk mitigations
• Draft initial risk assessments and support finalization of RACTs
• Transfer identified risks to the correct tracking system and support ongoing cross-functional risk reviews
• Advise on functional plans to mitigate identified risks
• Assess tools for remote data review and centralized statistical monitoring, identifying data quality and integrity risks
• Facilitate review of findings with internal cross-functional teams and sponsors
• Collaborate to identify Quality Tolerance Limits
• Develop and deliver training on risk assessment, centralized monitoring, and risk-based monitoring strategies
• Coach and mentor peers on functional delivery, project risk evaluation, and action implementation
• Collaborate across functions to ensure compliance with protocols, ICH/GCP, GPP, and country regulations
• Ensure inspection readiness for risk assessment and centralized monitoring scope
• Understand study scope of work, budget, and protocol content
• Escalate at-risk deliverables and out-of-scope activities to the Project Manager
• Participate in business development, including monitoring strategy, budget input, meetings, and proposal development

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Master's degree or health data sciences degree preferred
• Expert in Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements
• Expert in Risk-Based Monitoring Strategies processes and tools preferred
• Expert in Integrated Quality Risk Management (IQRM) theories
• Good computer skills and ability to embrace new technologies
• Mastery of MS Excel (sorting, filtering, calculating, pivoting)
• Mastery of Analytical Data Visualization Tools
• Knowledge of statistical analysis techniques, visualizations and tools, including Cluepoints, Medidata-CSA, Hy's Law, Funnel Plots, and Box and Whiskers
• Knowledge of Lean Six Sigma and RACT tools
• Strong analytical skills and understanding of statistical concepts
• Well-developed therapeutic expertise
• Excellent verbal and written communication skills
• Strong negotiation, organizational, and problem-solving skills
• Strong leadership, tactical, and strategic thinking skills
• Ability to anticipate and address critical issues and develop contingency plans proactively
• Knowledge of financial concepts related to forecasting, budgeting, and proposal generation
• Understanding of workflow processes, roles, and responsibilities across multiple functional areas
• Ability to understand, explain, and communicate project concepts and create detailed plans
• Ability to teach, train, and mentor employees at all levels
• Above-average attention to detail, accuracy, organizational, interpersonal, and team-oriented skills
• Excellent written and spoken communication and presentation skills
• Less than 30% travel required

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Inclusive culture
• Flexible remote work arrangement (Remote (Pre-Approved))