[Hiring] Senior Clinical Data Science Lead @ICON plc

Role Description

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.

• Oversee clinical data science workstreams, ensuring deliverables meet quality and timeline expectations.
• Lead Clinical Data Management activities across assigned studies, from study start-up through to database closure and clean database declaration.
• Provide oversight and guidance to Data Management staff assigned to specific protocols, including mentoring and training less experienced colleagues.
• Act as an experienced Clinical Data Management resource for global, cross-functional study teams and serve as 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
  • Protocol deviation documentation
• Collaborate with EDC developers on the specification and design of eCRFs and database structures and contribute to EDC User Acceptance Testing (UAT).
• Manage data cleaning activities, including identifying and issuing queries, incorporating query responses, tracking query status, and performing consistency checks on external data.
• Coordinate SAS programming requirements for edit checks and derivations and contribute to the preparation of data monitoring activities.
• Prepare data listings and extracts to support medical reviews, study reporting, and other cross-functional activities.
• Develop and coordinate database closure plans and ensure database closure activities are effectively communicated and delivered across the study team.
• Identify and communicate issues that could impact study timelines or data quality and work collaboratively with study teams to address them.
• Ensure Clinical Data Management activities are appropriately documented throughout the lifecycle of the study.
• Support training and education initiatives for Data Management colleagues to promote quality, productivity, and consistent working practices.

Qualifications

• 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 functions such as Study Management, Medical, EDC Development, Statistics, and Medical Writing.
• Demonstrated ability to interpret Clinical Study Protocols, Statistical Analysis Plans, and Medical Review Plans and translate these into appropriate 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.
• Strong project management, organisational, and self-management skills, with the ability to work independently and effectively manage priorities.
• Experience working within and helping lead global, cross-functional teams towards key study milestones such as First Patient First Visit readiness and timely clean database declaration.
• Strong written and verbal communication skills in English, with fluent spoken English required, alongside strong local-language communication skills.
• Good understanding of IT processes and databases used within Clinical Development.
• A proactive approach to continuous learning and professional development.

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.
• Benefits may vary depending on role and location.