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.
🔥 1 minute ago
🌐 United Kingdom, Spain, +2 more countries – Remote
⏰ Full Time
🟠 Senior
📊 Data Scientist
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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.
• Oversee clinical data management activities across the study lifecycle, ensuring deliverables meet quality, compliance, and timeline expectations • Lead day-to-day clinical data management activities for assigned studies and provide oversight of CROs and external vendors, including laboratories, ECG providers, and imaging vendors • Monitor vendor performance, timelines, and key performance indicators (KPIs), proactively identifying and mitigating data-related risks • Review and approve study documentation, including Data Management Plans (DMPs), CRF/eCRF specifications, Data Validation Plans (DVPs), database specifications, and Data Transfer Agreements (DTAs) • Participate in User Acceptance Testing (UAT) activities for Electronic Data Capture (EDC) systems and ensure database functionality aligns with protocol requirements • Oversee data quality review, reconciliation activities, query management, medical coding, safety data reconciliation, data cleaning, database lock readiness, and final data transfers • Manage clinical data management timelines to support key study milestones, including interim data cuts, analyses, and final database locks • Collaborate with cross-functional study teams and external partners to ensure compliance with ICH-GCP guidelines, FDA/EMA regulations, and applicable standard operating procedures • Lead study-related meetings with sponsors and vendors, maintaining clear communication and alignment across all stakeholders
• Bachelor's degree in a scientific, life sciences, healthcare-related, or equivalent discipline • Minimum of 5 years of clinical data management experience supporting multicentre clinical studies within the pharmaceutical, biotechnology, or CRO industry • Experience working in a sponsor environment or managing sponsor relationships through a CRO partnership model • Expertise with leading EDC platforms such as Medidata Rave, Oracle InForm, or Veeva Vault CDMS • Strong understanding of CDISC standards, medical coding dictionaries (MedDRA and WHO-DD), and data reconciliation processes • Deep knowledge of ICH-GCP guidelines, 21 CFR Part 11 requirements, and clinical data management best practices • Excellent communication, stakeholder management, and vendor oversight skills, with the ability to influence outcomes across cross-functional teams • Strong analytical and problem-solving abilities, with a track record of identifying and resolving complex data issues and study risks • Fluent English language skills, both written and verbal • Programming knowledge is desirable • Previous experience supporting tobacco or nicotine-related clinical studies and knowledge of EU clinical regulations would be an advantage
• 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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