Clinical Risk Manager

Pharmaceutical Research Associates, Inc; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player in healthcare intelligence is seeking a Clinical Risk Manager to drive innovation in clinical development. In this pivotal role, you will oversee risk management for global studies, ensuring adherence to SOPs and ICH-GCP guidelines. Your expertise will guide cross-functional teams in effective decision-making and risk mitigation strategies, contributing to the success of clinical trials. This is an exciting opportunity to be part of a diverse and inclusive environment that values high performance and work-life balance, offering a comprehensive benefits package designed to support you and your family.

Benefits

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Life assurance

Flexible optional benefits

Qualifications

• 7+ years in life sciences with 4 years in biopharmaceutical clinical research.
• Experience with CROs and risk management in clinical trials.

Responsibilities

• Lead risk management for clinical studies ensuring compliance with guidelines.
• Collaborate with teams to develop risk mitigation strategies.

Skills

Clinical Research

Risk Management

Cross-functional Collaboration

Data Analysis

Education

BS/BA/BSc in Sciences

Registered Nurse (RN)

Tools

CT-RACT Tool

Job description

Overview

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.

Responsibilities

What you will be doing:

The Clinical Risk Manager will coordinate and oversee the execution of risk management for GCPM managed studies, globally oversee the quality of risk management for studies at a global level. The Risk Manager collaborates with cross functional stakeholders to ensure continuous, timely and quality risk management.

1. Leading the Clinical Study Team to drive effective decision making for risk management.
2. Ensuring risk management implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines.
3. Responsible for CT-RACT completion and updates (by the CST) throughout the lifecycle of the clinical study.
4. Input to the development of the study protocol and functional plans.
5. Plan and lead high quality risk management discussions and reviews, including the identification and review of risks, critical data & critical processes.
6. Guide team on the process, requirements and how to complete the CT-RACT.
7. Review and ensure holistic quality (e.g. risk grading has sufficient rationale, not responsible to ensure inclusion of the appropriate study risks).
8. Review adherence to timelines and requirements.
9. Responsible for feedback on risks to protocol development.
10. Support the development of risk mitigation strategies.
11. Lead reviews of mitigation effectiveness.
12. Analyse, summarize and report findings to inform future study design and library of mitigations.
13. Track and oversee completion of mitigation actions – progress reports to CST.
14. Provide advice on the development of functional plans.
15. Provide advice and input to functional plan updates - drive RBSE thinking.
16. Provide advice on linking risks to the standard KRIs, and identify study-specific KRIs.
17. Provide ongoing feedback for CT-RACT tool enhancements.
18. Support messaging, training and roll out of tool enhancements.
19. Extended member of the (G)CST: Agenda-driven attendance at Study Team Meetings for topics of CT-RACT, Functional Plan reviews, KRI identification.

Qualifications

You Are:

1. BS/BA/BSc in the sciences or RN.
2. Seven (7) years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company.
3. Experience or oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.).
4. Experience as a Risk Manager at a CRO or pharmaceutical company.

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 maximise savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits. ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.