Clinical Data Configuration Engineer (FSP – SDTM Programming & Mapping)
Location: UK (Livingston) / India (Bangalore) | Remote/Hybrid (Office or Home)
Job Type: Full-Time
Company: ICON plc
Job ID: JR145128
About the Role
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a Clinical Data Configuration Engineer (FSP – SDTM Programming & Mapping) to join its high-performing team. This role is critical in designing, configuring, and optimizing clinical data systems to support efficient and compliant clinical trial execution.
The ideal candidate will bring deep expertise in SDTM standards, clinical data mapping, and system configuration, contributing to innovation in clinical development and ensuring alignment with regulatory expectations.
Key Responsibilities
Lead the design and development of clinical data systems aligned with study protocols and operational requirements
Configure, integrate, and test clinical systems to ensure optimal performance and usability
Develop and own SDTM specifications, including mapping rules and dataset structures
Interpret CDISC/SDTM standards and implement study-specific or global data standards
Collaborate with cross-functional teams (clinical, data management, biostatistics) to enhance system capabilities
Ensure quality control (QC) and adherence to data standards across deliverables
Provide strategic input on clinical data technologies and process improvements
Stay updated with evolving industry standards, regulatory guidelines, and emerging tools
Required Qualifications & Experience
Master’s degree in Computer Science, Life Sciences, or a related field
Minimum 5 years of experience in clinical data programming, SDTM mapping, or data standards roles
Strong expertise in CDISC and SDTM standards
Proven experience in SDTM specification creation, review, and ownership
Ability to define mapping strategies and variable derivations based on standards
Hands-on experience with SDTM mapping rules and dataset development
Understanding of end-to-end clinical data flow (raw data to SDTM datasets)
Experience in quality control and standards compliance
Familiarity with SAS and/or R programming (programming secondary to standards expertise)
Preferred Skills
Experience with R programming
Knowledge of CRF annotation and specification review
Background in data standards teams with SDTM focus
Why Join ICON?
ICON is committed to fostering a culture of innovation, inclusion, and excellence. Employees benefit from a collaborative global environment and opportunities for continuous professional growth.
Key Benefits Include:
Competitive salary packages
Generous annual leave policies
Comprehensive health insurance options
Retirement and long-term savings plans
Global Employee Assistance Programme (24/7 well-being support)
Life insurance coverage
Flexible benefits (childcare support, gym memberships, travel subsidies, and more)
Diversity, Equity & Inclusion
ICON is an equal opportunity employer committed to building an inclusive workplace free from discrimination and harassment. All qualified applicants will be considered without regard to race, gender, disability, or other protected characteristics.
Application Note
Candidates who may not meet every requirement are still encouraged to apply. ICON values diverse experiences and recognizes potential across a range of backgrounds.
This role is ideal for professionals seeking to advance their career in clinical data standards, SDTM programming, and clinical system innovation within a globally recognized CRO environment.
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China | Quarry Bay |Liaoning :
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