Risk Based Study Manager

ICON Strategic Solutions; United States; Remote; USD 120,000 - 170,000; Full time

Job summary

ICON Strategic Solutions is seeking aRisk-Based Study Management Lead to provide end-to-end risk oversight for assigned clinical studies, ensuring patient safety, data quality, and trial integrity throughout the lifecycle.

The role collaborates with the Clinical Research Manager and study team to drive proactive risk mitigation. Based anywhere in the US, the position emphasizes strategic leadership, cross-functional facilitation, and inspection readiness.

Qualifications

• Experience in clinical trial operations, study management, monitoring, or centralized oversight.
• Solid understanding of risk-based monitoring and study management principles.
• Knowledge of ICH-GCP, regulatory standards, and quality frameworks.
• Strong facilitation skills with confidence leading cross-functional discussions.
• Analytical mindset with the ability to interpret data, trends and signals.
• Excellent communication and stakeholder management skills.
• Ability to operate independently while collaborating effectively with sponsor and ICON team.

Responsibilities

• Lead and maintain study-level risk assessments for assigned sponsor studies.
• Facilitate and chair cross-functional risk review meetings, ensuring focus on critical data and processes.
• Drive proactive identification, discussion, and documentation of study risks.
• Partner closely with the CRM and study team to ensure aligned oversight and follow-through on mitigation actions.
• Review centralized monitoring outputs, KRIs, KPIs, and trends to detect emerging or systemic risks.
• Support issue escalation, root cause analysis, and risk mitigation planning.
• Ensure risk-based activities align with set principles and sponsor expectations.
• Contribute to inspection readiness through clear documentation and defensible oversight decisions.

Skills

Clinical trial operations

Risk-based monitoring

Stakeholder management

Cross-functional facilitation

Data interpretation

Job description

Program Manager

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Risk‑Based Study Management Lead, you will provide end‑to‑end risk oversight for assigned clinical studies, ensuring risks to patient safety, data quality, and trial integrity are proactively identified, discussed, and managed throughout the study lifecycle.

You will work in close partnership with the Clinical Research Manager (CRM) and broader study team, facilitating risk‑focused discussions and driving clear, practical mitigation strategies.

This role can be based anywhere in the US

Key Responsibilities

• Lead and maintain study‑level risk assessments for assigned sponsor studies
• Facilitate and chair cross‑functional risk review meetings, ensuring focus on critical data and processes
• Drive proactive identification, discussion, and documentation of study risks
• Partner closely with the CRM and study team to ensure aligned oversight and follow‑through on mitigation actions
• Review centralized monitoring outputs, KRIs, KPIs, and trends to detect emerging or systemic risks
• Support issue escalation, root cause analysis, and risk mitigation planning
• Ensure risk‑based activities align with set principles and sponsor expectations
• Contribute to inspection readiness through clear documentation and defensible oversight decisions

What You Bring

• Experience in clinical trial operations, study management, monitoring, or centralized oversight
• Solid understanding of risk‑based monitoring and study management principles
• Knowledge of ICH‑GCP, regulatory standards, and quality frameworks
• Strong facilitation skills with confidence leading cross‑functional discussions
• Analytical mindset with the ability to interpret data, trends and signals
• Excellent communication and stakeholder management skills
• Ability to operate independently while collaborating effectively with sponsor and ICON team

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well‑being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well‑being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here