Hybrid Clinical Data Configuration Engineer – SDTM Programming, Mapping

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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

Clinical Data Configuration Engineer – SDTM Programming, Mapping

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Postgraduate Degree

Location requirements

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