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Lead Data Manager
ICON plc. Lead end-to-end clinical data management start-up activities from protocol review through specification development, database build, testing, validation, and production go-live .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical data management, including protocol review, database design, and compliance with CDISC standards. Proven ability to lead cross-functional teams and manage project timelines while ensuring data integrity and regulatory adherence.
Highest-signal resume keywords
Clinical Data ManagementProtocol ReviewCDISC StandardsData AnalysisProject Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data AnalysisStatistical SoftwareData Visualization TechniquesECRF Design PrinciplesDatabase BuildTesting and ValidationDefect DocumentationSOP ComplianceICH-GCP ComplianceClinical Data Standards
Soft Skills
Analytical SkillsProblem-Solving SkillsCommunication SkillsLeadership SkillsCollaboration Skills
Tools & Technologies
ETMFSandbox TestingUser Acceptance Testing
Industry Keywords
Clinical ResearchData ManagementRegulatory RequirementsLife SciencesComputer Science
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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