Lead Data Manager
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Job Description
Lead Data Manager overseeing clinical trial data management start-up, database builds, testing, and go-live. Supporting ICON’s sponsor-dedicated clinical research services and global treatment development.
Responsibilities:
- 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 protocols to identify data collection requirements, build risks, inconsistencies, and impacts to database design or downstream processes
- Translate protocol requirements into study build specifications, including visit schedules, assessments, eCRFs, dosing, data collection, and edit checks
- Apply clinical data standards, including CDISC standards, eCRF design principles, field and variable conventions, and approved standard forms
- Partner with the Standards team to implement protocol-specific modifications
- Collaborate with Study Execution Teams, Medical Data Review, Programming, Data Management, Standards, and other stakeholders
- Plan and oversee sandbox testing and user acceptance testing, including defect documentation, resolution, retesting, and system-readiness confirmation
- Manage timelines, dependencies, deliverables, risks, and issue resolution for database go-live
- Assess and manage the data management impact of protocol amendments and post-go-live changes
- Maintain accurate data management start-up documentation in the eTMF
- Ensure deliverables comply with SOPs, ICH-GCP, regulatory requirements, and internal quality standards
- Manage day-to-day clinical data science activities and support team delivery
Requirements:
- 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%)
- Legal right to work in the country where the role is based
Benefits:
- 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
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