Senior Clinical Data Science Lead

About the Role ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. As a Senior Clinical Data Science Lead at ICON, you will lead the analysis, interpretation, and management of clinical data to drive the success of our clinical trials. What You'll Do

• Lead clinical data science activities across global clinical trials, ensuring high-quality, timely, and regulatory-compliant data delivery.
• Act as the primary data lead within cross-functional study teams, partnering with sponsors and internal stakeholders.
• Ensure alignment with agreed timelines, scope, and quality expectations. Drive study start-up activities including EDC build, system integrations (ePRO, IRT, eCOA), and user acceptance testing (UAT).
• Lead the development and execution of key data documentation such as Data Management Plans, Data Review Plans, and Edit Check Specifications.
• Oversee data cleaning, query management, and cross-functional data review processes.
• Manage external data reconciliation and vendor data integration activities.
• Lead database lock activities (interim and final), ensuring inspection readiness and data integrity.
• Identify and mitigate risks, proactively resolving complex data-related issues and escalations.
• Ensure compliance with CDISC standards, ICH-GCP, and regulatory requirements.
• Contribute to budget management, KPI tracking, and continuous improvement initiatives.
• Drive innovation through adoption of new technologies and data science approaches. What We're Looking For
• Education: Bachelor’s degree in Life Sciences, Health Sciences, or a related scientific/technical discipline.
• Industry Experience: 6–10+ years of progressive experience in clinical data management or clinical data science within a CRO or pharmaceutical environment.
• Study Leadership: Proven track record leading data management activities across the full clinical trial lifecycle (start-up, conduct, and close-out). Minimum of 3 years serving as the primary lead on complex, in-house studies, or 5+ years of hands-on experience driving data review and reconciliation (including EDC, external vendors, eCOA, IRT, and SAEs).
• Vendor & Oversight Management: Strong experience in vendor oversight and managing outsourced data delivery models.
• Technical Expertise: Hands-on experience with Electronic Data Capture systems (Veeva EDC preferred) and external data integrations.
• Regulatory & Compliance: In-depth understanding of clinical trial processes, regulatory frameworks (ICH-GCP, FDA), and data workflows. Experience supporting regulatory submissions (NDA/CTD) is highly advantageous.
• Core Competencies: Exceptional project management, organizational, and proactive problem-solving skills. Excellent communication and negotiation skills, with a demonstrated ability to influence stakeholders in a matrix environment. Ability to work independently, mitigate data risks, and thrive within fast-paced, global teams. Nice to Have
• CDISC SDTM knowledge (preferred).
• Experience supporting regulatory submissions (NDA/CTD) is advantageous. Compensation & Benefits
• ICON offers competitive salary and a range of benefits designed to support well-being and work-life balance across countries.
• Benefits examples include: various annual leave entitlements, health insurance options, retirement planning offerings, LifeWorks EAP with 24-hour access to a global network, life assurance, flexible country-specific optional benefits (childcare vouchers, bike schemes, gym discounts, travel subsidies, health assessments), and more. For full details, visit our careers site. -ICON is committed to inclusion and providing an accessible environment for all candidates. Equal opportunity employment and reasonable accommodations are available upon request.