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.
Responsibilities:
- Leading Clinical Data Management activities across assigned studies, from study start-up through to database closure and clean database declaration.
- Providing oversight and guidance to Data Management staff assigned to specific protocols, including mentoring and training less experienced colleagues.
- Acting as an experienced Clinical Data Management resource for global, cross-functional study teams and serving as an escalation point for study-related data management matters.
- Developing and maintaining study-specific data management components and specifications, including eCRFs, study metadata, edit checks, Data Validation Documents, and protocol deviation documentation.
- Collaborating with EDC developers on the specification and design of eCRFs and database structures and contributing to EDC User Acceptance Testing (UAT).
- Managing data cleaning activities, including identifying and issuing queries, incorporating query responses, tracking query status, and performing consistency checks on external data.
- Coordinating SAS programming requirements for edit checks and derivations and contributing to the preparation of data monitoring activities.
- Preparing data listings and extracts to support medical reviews, study reporting, and other cross-functional activities.
- Developing and coordinating database closure plans and ensuring database closure activities are effectively communicated and delivered across the study team.
- Identifying and communicating issues that could impact study timelines or data quality and working collaboratively with study teams to address them.
- Ensuring Clinical Data Management activities are appropriately documented throughout the lifecycle of the study.
- Supporting training and education initiatives for Data Management colleagues to promote quality, productivity, and consistent working practices.
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 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.
Rewards & 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