Description
As a Clinical Data Risk Manager at ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.
You will be responsible for successfully implementing and coordinating RBQM procedures at the study level, including initial and recurring risk identification, assessment, centralized risk monitoring, and mitigation activities within the RBQM framework.
Key responsibilities:
- Implement RBQM procedures for assigned studies
- Develop study-specific content and lead RBQM training and kick-off meetings
- Author and implement study-specific RBQM plans
- Lead risk assessment meetings and engage cross-functional study team members
- Partner with the RBQM system configuration team to ensure risk indicators are programmed and functioning correctly
- Perform periodic central monitoring of aggregate data to identify emerging risks and issues
- Lead risk review meetings and facilitate root cause identification and mitigation strategies
- Ensure corrective actions and preventative actions are properly documented and implemented
- Monitor the effectiveness of study risk mitigation actions and make recommendations for adjustments
- Create signal and trending reports for study teams
- Maintain up-to-date and accurate documentation of RBQM activities
- Support and participate in internal and external audits and inspections
Requirements:
- Bachelor's degree in a health-related field or international equivalent
- Minimum 6 years of experience in the pharmaceutical or CRO industry
- Minimum 2 years of experience in Risk-Based Quality Management
- Minimum 2 years of managerial and supervisory experience
- Robust understanding of the drug development process and clinical trial execution
- Knowledge of industry regulatory standards, including 21 CFR Part 11, ICH E6, and ICH E8 (GCP)
- Experience in risk management, sponsor audits, and health authority inspections
- Knowledge of RBQM IT systems or other data analytic systems
- Demonstrated ability to analyze data, identify patterns, and make recommendations for improvement
- Excellent teamwork, organizational, interpersonal, and problem-solving skills
Benefits:
- Competitive base salary and performance-related incentives
- Health and wellbeing programs, including medical, dental, and vision coverage
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programs and wellbeing resources
- Learning and development opportunities through structured training and career pathways