Principal Clinical Data Science Lead

🔥 44 minutes ago

🌐 United Kingdom, South Africa – Remote

🇬🇧 United Kingdom – Remote 🇿🇦 South Africa – Remote

⏰ Full Time

🟠 Senior

📊 Data Scientist

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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

• Lead Clinical Data Management activities across assigned studies from study start-up through database closure and clean database declaration • Provide oversight and guidance to Data Management staff, including mentoring and training less experienced colleagues • Act as an experienced Clinical Data Management resource for global, cross-functional study teams and an escalation point for study-related data management matters • Develop and maintain study-specific data management components and specifications, including eCRFs, study metadata, edit checks, Data Validation Documents, and protocol deviation documentation • Collaborate with EDC developers on eCRF and database structure specifications and contribute to EDC User Acceptance Testing • Manage data cleaning activities, queries, query responses, query status, and consistency checks on external data • Coordinate SAS programming requirements for edit checks and derivations and contribute to data monitoring activities • Prepare data listings and extracts for medical reviews, study reporting, and cross-functional activities • Develop and coordinate database closure plans and ensure closure activities are communicated and delivered across the study team • Identify and communicate issues affecting study timelines or data quality and collaborate with study teams to resolve them • Ensure Clinical Data Management activities are documented throughout the study lifecycle • Support training and education initiatives for Data Management colleagues

🎯 Requirements

• Bachelor’s degree or equivalent in Natural Sciences, Informatics, Medical Documentation, or a related discipline • 5+ years of experience as a Clinical Data Manager, with significant responsibility within clinical projects and study teams • Strong understanding of the drug development process and extensive experience with clinical data management methodologies and technologies • Proven experience managing clinical data from study start-up through to clean database declaration • Experience working within global, cross-functional teams and collaborating with Study Management, Medical, EDC Development, Statistics, and Medical Writing • Ability to interpret Clinical Study Protocols, Statistical Analysis Plans, and Medical Review Plans and translate them into data management specifications • Experience developing specifications including CRFs, metadata, protocol deviation documents, and edit check specifications • Good understanding of relevant clinical research regulations and guidelines, including ICH and GCP • Experience training and/or mentoring junior Data Management colleagues, with the ability to provide guidance and act as an escalation point • Experience helping lead global, cross-functional teams toward key study milestones • Strong written and verbal communication skills in English, with fluent spoken English required • Strong local-language communication skills • 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

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