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:

• Leading end-to-end clinical data management start-up activities from protocol review through specification development, database build, testing, validation, and production go-live.
• Reviewing draft and approved protocols to identify data collection requirements, build risks, inconsistencies, and potential impacts to database design or downstream processes.
• Translating protocol requirements into complete and accurate study build specifications, including visit schedules, assessments, eCRFs, dosing, data collection requirements, and edit check specifications.
• Applying clinical data standards, including CDISC standards, eCRF design principles, field and variable conventions, and approved standard forms, to ensure consistent and compliant study configuration.
• Partnering with the Standards team to leverage existing standards and define, document, and implement protocol-specific modifications when needed.
• Collaborating 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.
• Planning, coordinating, and overseeing sandbox testing and user acceptance testing (UAT), including documentation of defects, issue resolution, retesting, and confirmation of system readiness.
• Managing start-up timelines, dependencies, deliverables, risks, and issue-resolution activities to ensure timely and successful database go-live.
• Assessing and managing the data management impact of protocol amendments and post–go-live changes, including updates to specifications, system configuration, testing, validation, and documentation.
• Maintaining complete, accurate, and timely data management start-up documentation in the eTMF.
• Ensuring all data management start-up deliverables comply with applicable SOPs, ICH-GCP, regulatory requirements, and internal quality standards.

Your Profile:

You will have solid clinical data experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience:

• 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%).

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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.