The Risk-Based Quality Management (RBQM) Risk surveillance Lead is responsible driving the adoption of RBQM practice at trial level and oversee the implementation, and continuous improvement. Risk Surveillance Lead works within a matrix environment and has overall accountability for the surveillance of the quality risks across the assigned trials and program, enabling a comprehensive clinical quality (GCP) risk governance. The role demonstrates leadership in influencing and improving clinical trial quality through the expert understanding of clinical trial protocols, processes, regulatory requirements, and quality management principles.

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 definedResponsible 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 systemConduct of periodic central surveillance of the aggregate data at the study and program level, leveraging available analytics/visualizations in the RBQM system, to identify emerging risks and/or issuesFacilitate risk review meetings and discussions with study / program team members to effectively communicate and discuss the findings, support, and encourage robust root cause identification and mitigation strategiesSupports and participates in internal and external audits and inspectionCollaborate 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 processesActs 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 benefitMay perform line management of other (junior) staff within RBQM Team

Key Performance Indicators

Adoption rate of RBQM across trial portfolioEffectiveness in risk identification, assessment, and mitigation (number of risks identified, assessed, and successfully mitigated).Stakeholder satisfaction measured through structured feedback and surveys conducted periodically.Insights generated from metrics leading to Process and Quality Risks improvements.

Qualifications

Minimum of 6 years of experience in the pharmaceutical or CRO industryMinimum of 2 years of experience in Risk Based Quality ManagementRobust understanding of the drug development process and clinical trial executionKnowledge 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 ActionsKnowledge of RBQM IT systems or other data analytic systemsDemonstrated ability to analyze data, identify patterns and make recommendations for improvementDemonstrated ability to effectively lead cross functional team meetingsExperience forming cross-functional collaborations; strong interpersonal skillsSupports a culture of continual improvement and innovation; promotes knowledge sharingAbility to influence without authorityThinks creatively; challenges the status quo

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