Risk Based Study Manager

US, Blue Bell (ICON) · Remote
Full-time
Posted Nov 10, 2026

Skills

CRM
Google Cloud
Root Cause Analysis

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

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

•Competitive base salary and performance related incentives

•Health and wellbeing programmes including medical, dental, and vision coverage where applicable

•Retirement and pension plans

•Life assurance and disability coverage

•Employee assistance programmes and wellbeing resources

•Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here .

Are you a current ICON Employee? Please click here to apply