Clinical Risk Manager I

Overview

Premier Research seeks a Clinical Risk Manager I to join the Global Clinical Strategy and Delivery team in Spain. You will drive risk-based monitoring strategies and quality risk management across studies, collaborating with cross-functional teams to ensure patient safety and data integrity. You’ll develop IQRMPs and support RBM readiness, parameters, and stakeholder communications. This role blends scientific rigor with process improvement to enable efficient, compliant clinical programs. You’ll contribute to innovative medical research that supports patients and sponsor goals.

Responsibilities

• Support Clinical Bidder, Proposals and Business Development by providing rationale for the monitoring strategy based on risk assessment
• Complete the study RACT for complex/global trials, identifying Critical Data/Processes and cross-functional mitigations
• Evaluate and discuss QTL parameters with required functions
• Ensure proposed monitoring strategy is fit for purpose and risk-proportionate
• Ensure Central Monitor has tools for aggregated data reviews or other methods
• Create configuration notes for Clinical Analytics programmers
• Author the Integrated Quality Risk Management Plan (IQRMP) for assigned studies
• Serve as SME on Risk Management and RBM for assigned studies
• Support functional leads in completing project plans with mitigations
• Support ongoing cross-functional protocol execution risk reviews throughout the project life cycle
• Support Kick Off meetings for new awards/opportunities
• Ensure inspection readiness related to Risk Management and RBM strategy through documentation
• Build knowledge of RBQM processes and share learnings within the team

Key requirements

• 8+ years of clinical research experience related to RBQM, Central Monitoring and Project Management
• Subject matter expertise on ICH-GCP, ICH E6 (R2 + R3) Guidelines and RACT tools (preferred)
• Subject matter expertise on RBQM, KRI, QTLs, QbD, Centralized Monitoring, Budgeting and Contracts
• Understanding of RBQM concepts (KRI, QTLs, QbD, Centralized Monitoring, budget)
• Strong analytical, computational, judgment and decision-making abilities
• Solid grounding in statistical concepts and Integrated Quality Risk Management (IQRM)
• Experience leading department/organizational process improvements
• Expertise with MS Excel, Business Intelligence tools and data visualization for decision making
• Experience collaborating with cross-functional global teams
• Excellent verbal and written English communication
• Willingness to travel up to 20% for sponsor meetings

• Excellent verbal and written communication
• Cross-functional collaboration
• Analytical thinking and sound judgment
• RBQM
• KRI
• QTLs

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