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About the role
Key responsibilities & impact- Design and analyse clinical trials, interpreting complex medical data
- Coordinate consulting and advisory services delivery, resolving issues, and developing team capability
- Develop tools to aid in the implementation and compliance of CDISC, Sponsor, and ICON standards
- Collaborate with cross-functional teams to define data collection strategies and standards for clinical trials
- Develop and maintain training and reference materials related to standards topics including CDASH, SDTM, Terminology, ADaM, define-XML and regulatory submission requirements
- Manage the development and maintenance of data management processes and tools
- Keep abreast of industry trends and regulatory updates related to data standards and ensuring their integration into ICON's practices
Requirements
What you’ll need- Bachelor's degree in life sciences, computer science, or a related discipline
- Extensive experience in clinical data management and standards within the pharmaceutical or biotechnology industry
- Advanced Proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards and relevant regulations (e.g., FDA, EMA)
- Excellent analytical and problem-solving skills with a keen attention to detail
- Excellent communication and collaboration abilities to work effectively in cross-functional teams
- Willingness to travel as required (approximately 15%)
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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical data managementCDISC standardsdata analysisdata collection strategiesregulatory submission requirementsCDASHSDTMADaMdefine-XMLdata management processes
Soft Skills
analytical skillsproblem-solving skillsattention to detailcommunication abilitiescollaboration abilities