Clinical Data Risk Manager

ICON plc

. Implement and coordinate RBQM procedures at the study level .

Posted 11/9/2026full-timeRemote • Mexico, Brazil, Chile, Costa Rica, Colombia, PeruMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Risk Based Quality Management (RBQM) procedures, including risk assessment, data analytics, and compliance with regulatory standards. Proven ability to lead cross-functional teams, manage risk mitigation strategies, and support audits and inspections in the pharmaceutical or CRO industry.

Highest-signal resume keywords

Risk Based Quality ManagementRegulatory Standards ComplianceData AnalyticsCross-Functional Team LeadershipRisk Assessment

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk ManagementRoot Cause AnalysisCorrective Actions Preventive ActionsClinical Trial ExecutionData AnalysisRBQM IT SystemsStudy Risk AssessmentsSignal and Trending ReportsQuality Tolerance LimitsStudy-Specific RBQM Plans

Soft Skills

Interpersonal SkillsInfluencing Without AuthorityProblem-Solving SkillsAssertive CommunicationCollaboration

Industry Keywords

Pharmaceutical IndustryCRO Industry21 CFR Part 11ICH E6ICH E8Change ManagementQuality ManagementAuditsInspectionsBest Practices

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Implement and coordinate RBQM procedures at the study level
Review study protocols and facilitate development of Study Risk Assessments defining critical data, critical processes, key risk indicators, and quality tolerance limits
Develop study-specific content and lead RBQM training and kick-off meetings
Author and implement study-specific RBQM plans
Lead risk assessment and risk review meetings with cross-functional study teams
Partner with RBQM system configuration teams to ensure risk indicators, quality tolerance limits, analytics, and visualizations function as required
Perform periodic central monitoring of aggregate data at study, region, country, site, and patient levels
Identify emerging risks and issues and facilitate root cause identification and mitigation strategies
Ensure corrective and preventive actions are documented, assigned, and implemented
Monitor effectiveness of risk mitigation actions and recommend adjustments
Create signal and trending reports for study teams
Partner with Adaptive Monitoring Excellence on signals requiring adjustments to targeted source data verification and source data review plans
Maintain accurate documentation of RBQM activities
Support internal and external audits, inspections, and regulatory interactions
Maintain quality, consistency, and compliance with RBQM procedures across studies
Identify and share best practices, case studies, failures, and process improvement opportunities
Act as a change agent, champion, subject matter expert, and RBQM methodology point of contact
Potentially manage junior staff within RBQM Operations

Requirements

What you’ll need

Bachelor’s Degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work experience
Minimum of 6 years of experience in the pharmaceutical or CRO industry
Minimum of 2 years of experience in Risk Based Quality Management
Minimum of 2 years managerial and supervisory experience
Robust understanding of the drug development process and clinical trial execution
Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP)
Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies, and Corrective Actions Preventive Actions
Knowledge of RBQM IT systems or other data analytic systems
Demonstrated ability to analyze data, identify patterns and make recommendations for improvement
Demonstrated ability to effectively lead cross functional team meetings
Experience forming cross-functional collaborations
Strong interpersonal skills
Ability to influence without authority
Pragmatic and willing to drive and support change
Comfortable with ambiguity
Excellent teamwork, organizational, interpersonal, and problem-solving skills
Assertive and collaborative communication style
Aptitude for data analytics; analytical mind
Attention to detail and a critical thinker
Ability to effectively communicate cross functionally with people of various levels
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
Reasonable accommodations during the recruitment process
Equal opportunity and inclusive workplace