Senior Manager - RBQM Operations (Remote)

About the role

ICON Strategic Solutions is hiring a Clinical Data Risk Manager (RBQM Operations) for the LATAM region, working remotely. The role reports to a Director of RBQM Operations and is responsible for implementing and coordinating RBQM procedures at the study level, including risk identification, assessment, centralized risk monitoring and mitigation. It is offered in a sponsor-dedicated model.

Key responsibilities

• Implement RBQM procedures for assigned studies and author the study-specific RBQM plan
• Review study protocols and help develop the Study Risk Assessment, including critical data, processes and key risk indicators with quality tolerance limits
• Lead RBQM training, kick-off meetings, risk assessment and risk review meetings, and facilitate root cause analysis and mitigation strategies
• Partner with the RBQM system configuration team so that risk indicators and visualizations work as required
• Monitor aggregate data centrally and create signal and trending reports for study teams
• Ensure corrective and preventative actions are documented, assigned and implemented, and monitor their effectiveness
• Work with the Adaptive Monitoring Excellence team on signals needing review, and support inspections and regulatory interactions related to RBQM
• Maintain accurate documentation, take part in audits and inspections, share best practices and act as the RBQM subject matter expert for study teams
• May manage junior staff within RBQM Operations

Required profile

• Bachelor's degree in a health-related or life science field, or equivalent combination of education, training and experience
• Minimum 6 years of experience in the pharmaceutical or CRO industry
• Minimum 2 years in Risk Based Quality Management and 2 years of managerial and supervisory experience
• Understanding of the drug development process and clinical trial execution
• Knowledge of 21 CFR Part 11, ICH E6 and ICH E8 (GCP)
• Legal right to work in the country where the role is based

Required skills

• Risk management, sponsor audits, health authority inspections, root cause analysis and CAPA
• Knowledge of RBQM IT systems or other data analytic systems
• Data analysis, pattern recognition and leadership of cross-functional meetings

What we offer

• Competitive base salary and performance-related incentives
• Medical, dental and vision coverage where applicable, retirement and pension plans, life assurance and disability coverage
• Employee assistance programmes, learning and development opportunities