Lead Data Manager - Clinical Data Science

About the role

ICON Strategic Solutions is hiring a Lead Data Manager in Barcelona to drive data science initiatives within study start-up clinical trials. Working in a sponsor-dedicated model, the role leads end-to-end clinical data management start-up activities, from protocol review through to database go-live, so that analyses provide meaningful insights for strategic decisions.

Key responsibilities

• Manage day-to-day clinical data science activities and support the team to deliver quality outcomes.
• Lead start-up activities from protocol review through specification development, database build, testing, validation and production go-live.
• Review protocols to identify data collection requirements, build risks and inconsistencies, and translate them into accurate study build specifications (visit schedules, assessments, eCRFs, dosing, edit checks).
• Apply clinical data standards such as CDISC and eCRF design principles, and partner with the Standards team on protocol-specific modifications.
• Work with Study Execution Teams, Medical Data Review, Programming, Data Management and others to clarify requirements and coordinate study configuration.
• Plan and oversee sandbox testing and UAT, including defect documentation, issue resolution and confirmation of system readiness.
• Manage start-up timelines, dependencies, risks and deliverables, and assess the impact of protocol amendments and post-go-live changes.
• Maintain complete, accurate and timely data management start-up documentation in the eTMF, in line with SOPs, ICH-GCP and regulatory requirements.

Required profile

• 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.
• Ability to manage competing priorities and develop a team.
• Willingness to travel approximately 15%.
• Legal right to work in the country where the role is based.

Required skills

• Strong expertise in statistical software and data visualization techniques.
• Knowledge of CDISC standards and eCRF design principles.
• Analytical, problem-solving, communication and leadership skills.

What we offer

• 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 learning and development opportunities.