Major Accountabilities:

• Facilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory etc.) associated to critical-to-quality (CtQ) data and processes, including definition of quality tolerance limits (QTLs), evaluation of risks based on likelihood, detectability, impact, and ensures mitigation strategy / plans are defined
• Responsible for drafting, maintaining, and archiving the study specific documentation of risk management activities e.g., Integrated Quality Risk Management Plan (IQRMP)
• Partners with the RBQM system configuration team to ensure risk indicators, quality tolerance limits and other analytics/visualizations are programmed and functioning per operational requirements in the RBQM system
• Conduct of periodic central surveillance of the aggregate data at the study and potentially program level, leveraging available analytics/visualizations in the RBQM system, to identify emerging risks and/or issues
• Facilitate risk review meetings and discussions with study and potentially program team members to effectively communicate and discuss the findings, support, and encourage robust root cause identification and mitigation strategies
• Supports and participates in internal and external audits and inspection
• Collaborate with training departments to support training initiatives and aid in the adoption of the RBQM approach.
• Identifies and shares lessons learned, best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with RBQM processes
• Acts as a change agent, champion, subject matter expert and point of contact of RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefit

Experience:

Bachelor’s Degree in a health-related, life science area, or equivalent combination of education, training, and work experience

• Minimum of 4 years of experience in the pharmaceutical or CRO industry
• Preferred minimum of 1 years of experience in Risk Based Quality Management
• Robust understanding of the drug development process and clinical trial execution
• Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP)
• Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions
• Knowledge of RBQM IT systems or other data analytic systems
• Demonstrated ability to analyze data, identify patterns and make recommendations for improvement
• Demonstrated ability to effectively lead cross functional team meetings
• Experience forming cross-functional collaborations; strong interpersonal skills
• Supports a culture of continual improvement and innovation; promotes knowledge sharing
• Ability to influence without authority
• Thinks creatively; challenges the status quo

Languages:

English: fluent written and spoken

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