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ICON plc

Risk Based Study Manager

ICON plc

. Lead and maintain study‑level risk assessments for assigned sponsor studies .

Posted 11/10/2026full-timeRemote • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical trial operations and risk-based monitoring, with strong analytical skills to interpret data and trends. Proven ability to lead cross-functional discussions and ensure compliance with regulatory standards and quality frameworks.

Highest-signal resume keywords
Clinical Trial OperationsRisk-Based MonitoringICH-GCP KnowledgeFacilitation SkillsStakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Study ManagementRisk AssessmentData InterpretationRoot Cause AnalysisMitigation Planning
Soft Skills
Analytical MindsetExcellent CommunicationCollaborationIndependent Operation
Tools & Technologies
Centralized Monitoring OutputsKey Risk IndicatorsKey Performance Indicators
Industry Keywords
Regulatory StandardsQuality FrameworksInspection Readiness

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • 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

Requirements

What you’ll need
  • 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
  • Legal right to work in the country where the role is based

Benefits

Comp & perks
  • 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