Principal Clinical Data Science Lead

• 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.

• 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.
• 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.

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.