Senior Clinical Data Risk Analyst

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 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

• Serve as clinical risk management and central monitoring functional lead for multiple moderate-complexity studies • Perform clinical data analysis components of clinical studies • Facilitate RBQM and plan and select KRIs focused on identified risks • Design advanced analytics and programming specifications • Review centrally aggregated data to identify risks and issues affecting data integrity, patient safety, and regulatory compliance • Track signals, support system users, and communicate trends to internal and external stakeholders • Conduct QC and oversight activities within the Central Monitoring team • Lead evaluation of clinical trial data to identify potential risks and trends affecting study outcomes • Collaborate with cross-functional teams to develop and implement risk mitigation strategies • Oversee analysis of data discrepancies and inconsistencies and provide decision-making insights • Guide best practices for data governance and compliance in clinical research • Establish stakeholder partnerships around risk management processes and data quality standards • Mentor junior staff

🎯 Requirements

• 5+ years of experience in clinical data analysis or risk management in a clinical research organization or pharmaceutical company • Strong analytical skills with proficiency in statistical software and risk assessment methodologies • Attention to detail and a proactive approach to identifying and addressing data risks • Knowledge of at least 1 Clinical Data Management System (Medidata RAVE, InForm, Veeva, Cluepoints, Medidata Detect, JReview, etc.) • Ability to manage multiple studies simultaneously while handling changing priorities and competing deadlines • Excellent written and oral communication skills • Bachelor's degree or local equivalent in life sciences or related field preferred • Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above • Must read, write, and speak fluent English and host country language • Legal right to work in the country where the role is based • Applications must be submitted in English

🏖️ 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