Clinical Data Risk Manager

🔥 1 hour ago

🌐 Mexico, Brazil, +4 more countries – Remote

🇲🇽 Mexico – Remote 🇧🇷 Brazil – Remote 🇨🇱 Chile – Remote 🇨🇷 Costa Rica – Remote 🇨🇴 Colombia – Remote 🇵🇪 Peru – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🎲 Risk

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• 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

• 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

• 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

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