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.

Key Responsibilities Include:

• 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.