Clinical Risk Manager

ICON; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

Join a leading healthcare intelligence organization as a Clinical Risk Manager. You will oversee global risk management for clinical studies, ensuring quality and compliance. Collaborate with cross-functional teams to drive effective decision-making and support study design improvements. Enjoy a diverse culture with competitive benefits and opportunities for growth.

Benefits

Competitive Salaries

Health Insurance

Retirement Plans

Global Employee Assistance Programs

Life Assurance

Flexible Country-Specific Benefits

Childcare Vouchers

Gym Memberships

Qualifications

• Seven years of experience in life sciences or related fields.
• At least four years in clinical research within biotech, pharmaceutical, or CRO settings.

Responsibilities

• Coordinate and oversee risk management for GCPM managed studies globally.
• Lead the Clinical Study Team for effective decision-making.
• Monitor adherence to timelines and requirements.

Skills

Risk Management

Clinical Research

Decision-Making

Education

BS/BA/BSc in sciences

RN qualification

Job description

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development as a Clinical Risk Manager.

What you will be doing:

The Clinical Risk Manager will coordinate and oversee risk management for GCPM managed studies (early, late, and observational) globally. They will oversee the quality of risk management at a global level and collaborate with cross-functional stakeholders to ensure continuous, timely, and high-quality risk management.

• Lead the Clinical Study Team to drive effective decision-making for risk management.
• Ensure risk management implementation and conduct of studies in accordance with SOPs and ICH-GCP guidelines.
• Responsible for CT-RACT completion and updates throughout the study lifecycle.
• Contribute to the development of study protocols and functional plans.
• Plan and lead risk management discussions, including risk identification and review of critical data and processes.
• Guide the team on processes, requirements, and completion of CT-RACT.
• Review and ensure holistic quality, including risk grading rationale.
• Monitor adherence to timelines and requirements.
• Provide feedback on risks during protocol development.
• Support the development and review of risk mitigation strategies and effectiveness.
• Analyze, summarize, and report findings to inform future study design.
• Oversee completion of mitigation actions and report progress.
• Advise on functional plan development and updates, linking risks to KRIs.
• Provide feedback for CT-RACT tool enhancements and support training and rollout.
• Participate in Study Team Meetings, focusing on CT-RACT, functional plans, and KRI identification.

You Are:

• BS/BA/BSc in sciences or RN qualification.
• Seven years of experience in life sciences or related fields, including at least four years in clinical research within biotech, pharmaceutical, or CRO settings.
• Experience overseeing external research vendors.
• Experience as a Risk Manager at a CRO or pharmaceutical company.

What ICON can offer you:

We prioritize building a diverse culture that rewards high performance and nurtures talent. Our benefits include competitive salaries, health insurance, retirement plans, global employee assistance programs, life assurance, and flexible country-specific benefits such as childcare vouchers, gym memberships, and more. Visit our careers site for more details: https://careers.iconplc.com/benefits.

ICON is an equal opportunity employer committed to a discrimination-free workplace. We provide reasonable accommodations for applicants with disabilities. If interested, but unsure if you meet all requirements, we encourage you to apply—your skills may be a perfect fit.