Utility Engineer responsible for HVAC, BMS, and FMS systems in Clinical Supply Packaging & Shipping. Handle project management, validate facilities, and ensure patient safety at Novo Nordisk.
IP
Hybrid Clinical Data Configuration Engineer – SDTM Programming, Mapping
Posted 3 weeks ago
About the role
- Design and implement advanced clinical systems for ICON plc, ensuring alignment with study protocols and driving innovation to meet regulatory requirements.
Responsibilities
- Leading the design and development of clinical systems, ensuring alignment with study protocols and operational needs.
- Collaborating with cross-functional teams to identify opportunities for system enhancements and innovations in clinical trial processes.
- Overseeing system configuration, integration, and testing to ensure optimal functionality and user experience.
- Providing strategic guidance on the implementation of new technologies and best practices in clinical system design.
- Staying current with industry trends and advancements in clinical technology to drive continuous improvement initiatives.
Requirements
- Master degree in Computer science or relevant field
- 5 years work experience in similar role
- Strong SDTM and CDISC standards knowledge.
- Experience in SDTM specification creation, review, and ownership (not just execution).
- Ability to make mapping decisions based on standards and processes.
- Experience in SDTM mapping rules, variable derivations, and study-specific/global standards interpretation.
- QC experience to ensure team adherence to standards.
- Contribution to SDTM or standards development as needed.
- Familiarity with SAS and R for implementing specifications (programming is secondary).
- Understanding of end-to-end data flow from raw data to completed SDTM datasets.
- Ideal candidates may have worked in data standards teams with an SDTM focus.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Job title
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