Risk

• Design and implement RBQM strategies in accordance with TransCelerate’s methodology, including risk assessment, risk control, risk review, and risk reporting.
• Lead cross-functional teams in the development of study-specific Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs), and risk mitigation plans.
• Facilitate initial and ongoing risk assessments using tools such as RACT (Risk Assessment Categorization Tool).
• Ensure integration of RBQM principles into protocol design, monitoring plans, and data management strategies.
• Develop and manage centralized monitoring processes to identify data trends, anomalies, and potential risks across clinical sites.
• Collaborate with data management and biostatistics teams to define algorithms and dashboards for real-time data visualization and risk detection.
• Interpret centralized monitoring outputs to guide targeted site monitoring and recommend corrective actions.
• Serve as a subject matter expert (SME) for RBQM and centralized monitoring across clinical development teams.
• Provide training and guidance to internal stakeholders on RBQM principles and tools.
• Partner with Clinical Operations and Clinical Quality to ensure compliance with ICH E6(R2), GCP, and regulatory expectations.
• Monitor industry trends and regulatory updates related to RBQM and centralized monitoring.
• Evaluate and implement technology solutions that enhance risk detection and oversight capabilities.
• Contribute to internal audits and inspection readiness activities related to RBQM and centralized monitoring.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.

Risk-Based Quality Management (RBQM) Specialist – Temporary

Risk Analyst – Casualty

Employee Benefits, Risk Advisor

Risk Advisor – Employee Benefits

PRN Nurse Practitioner – Per Visit Health Risk Assessments

Risk Strategist