New · posted Nov 11
ICON · Pharmaceuticals
Risk Based Study Manager
- Remote, US
- Remote
- Full-time
- Manager
The role
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
What you need
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.
What you'll do
- 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
Pay and benefits
ICON didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Rewards & Benefits
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
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Equal opportunity, accessibility and legal noticesICON's statements, word for word
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
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
Manager roles in the US45 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $143,000 | $161,500 | $169,500 |
Comparisons: the base pay employers published on open Clinical Trial Management roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Trial Management
The general path across 81 open Clinical Trial Management roles on Regulatory Jobs, with the titles they carry most. Not ICON's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 22 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- Clinical trial conduct3
- GMP and compliance2
- Lab testing and methods2
- Documentation and SOPs2
- Investigations and CAPA1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Trial Management work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
Company hiring pulse
ICON on Regulatory Jobs
- 154
- Open roles
- 154
- Distinct roles
- 37
- Locations
By discipline
- Clinical148 92%
- Quality9 6%
- Regulatory4 2%
By level
- Associate & Specialist68 42%
- Senior & Principal65 40%
- Manager23 14%
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Risk Based Study Manager at ICON
Open until filled.