Risk Based Study Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and manage study-level risk assessments for designated sponsor studies.

• Lead and facilitate cross-functional risk review meetings, ensuring attention on critical data and processes.

• Promote the proactive identification, discussion, and documentation of study-related risks.

• Collaborate closely with the CRM and study team to ensure coordinated oversight and follow-through on mitigation strategies.

• Analyze centralized monitoring outputs, KRIs, KPIs, and trends to identify emerging or systemic risks.

• Assist in issue escalation, root cause analysis, and the development of risk mitigation plans.

• Ensure that risk-based activities are in line with established principles and sponsor expectations.

• Contribute to inspection readiness through precise documentation and justifiable oversight decisions.

⛳️ Requirements

• Background in clinical trial operations, study management, monitoring, or centralized oversight.

• Strong grasp of risk-based monitoring and study management principles.

• Familiarity with ICH-GCP, regulatory standards, and quality frameworks.

• Exceptional facilitation skills and confidence in leading cross-functional discussions.

• Analytical mindset capable of interpreting data, trends, and signals.

• Excellent communication and stakeholder management abilities.

• Capacity to work independently while effectively collaborating with both sponsor and ICON teams.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career advancement pathways.