Lead Data Manager

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.

As a Lead Data Manager at ICON, you will drive data science initiatives within study start up clinical trials, ensuring that our analyses provide meaningful insights that inform strategic decisions.

What You Will Do:

You will manage day-to-day clinical data science activities, supporting your team to deliver quality outcomes., * Lead end-to-end clinical data management start-up activities from protocol review through specification development, database build, testing, validation, and production go-live.

• Review draft and approved protocols to identify data collection requirements, build risks, inconsistencies, and potential impacts to database design or downstream processes.
• Translate protocol requirements into complete and accurate study build specifications, including visit schedules, assessments, eCRFs, dosing, data collection requirements, and edit check specifications.
• Apply clinical data standards, including CDISC standards, eCRF design principles, field and variable conventions, and approved standard forms, to ensure consistent and compliant study configuration.
• Partner with the Standards team to leverage existing standards and define, document, and implement protocol-specific modifications when needed.
• Collaborate with Study Execution Teams (SET), Medical Data Review (MDR), Programming, Data Management, Standards, and other cross-functional stakeholders to clarify requirements, resolve discrepancies, and coordinate study configuration activities.
• Plan, coordinate, and oversee sandbox testing and user acceptance testing (UAT), including documentation of defects, issue resolution, retesting, and confirmation of system readiness.
• Manage start-up timelines, dependencies, deliverables, risks, and issue-resolution activities to ensure timely and successful database go-live.
• Assess and manage the data management impact of protocol amendments and post-go-live changes, including updates to specifications, system configuration, testing, validation, and documentation.
• Maintain complete, accurate, and timely data management start-up documentation in the eTMF.
• Ensure all data management start-up deliverables comply with applicable SOPs, ICH-GCP, regulatory requirements, and internal quality standards.

You will have solid clinical data experience, with the ability to manage competing priorities and develop your team., * Bachelor’s degree in life sciences, computer science, or a related discipline

• Extensive experience in data analysis and project leadership within a clinical research setting.
• Strong expertise in statistical software and data visualization techniques.
• Exceptional analytical and problem-solving skills, with a focus on translating data into actionable insights.
• Excellent communication and leadership skills, with the ability to foster collaboration across diverse teams.
• Willingness to travel as required (approximately 15%)

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.