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Senior Clinical System Designer

  1. South Africa
2024-110479
  1. Clinical Data Management, Clinical Data Scientist Lead, Clinical Systems, Data Standards Consultant
  2. ICON Strategic Solutions
  3. Remote

About the role

Looking for a Senior Clinical System Designer within FSP model. 


What you will be doing:

  • Provides technical solutions for data management deliverables in the data collection capability.
  • Proactively engage in cross-functional EDC build Requirements, eCRF design meetings.
  • Ensures eCRF is built according to the latest standards and best practices, including edit checks and applicable integrations (IWRS, CTMS, etc.); translate protocol requirements into optimal data capture approaches; either build and deploy a trial in an EDC system or oversee eCRF build and updates by CRO or vendor to confirm quality and consistency with standards.
  • Responsible for QC on eCRF Forms/Fields, dynamics (DVRs/CFs), EDC integrations, etc., both on library and trial specific level;
  • Ensure non-eCRF technologies for data capture (e.g., ePRO, safety reporting, coding, IWRS) are deployed as per requirements, including integrations with other systems, platforms or reporting environments with timelines for consumable data outlined.
  • Creates tSDV technical specifications, Safety Gateway integration specifications and completes the Datamart mapping template.
  • Responsible for acquiring and maintaining working knowledge in the various and future evolving data collection tools applied in the clinical trial space such as Medidata Rave.
  • Support the development of eCRF standards and drive their implementation within the organization

Metrics/KPIs:

  • Metrics/KPIs governing these services are outlined in the QOP document

You are:

  • Bachelor’s degree or equivalent, in Computer Science or technical discipline with experience in clinical research.
  • Technical Data Management experience.
  • Technical Expertise in one or more of the following: eDC systems (Medidata, platform of tools), EDC integration tools, and general data capture platforms.
  • Experience working on a clinical trial.
  • Experience working in highly diverse teams within clinical research; cross-functional, global, multiregional.
  • Project management skills.
  • Highly organized with excellent written and verbal communication.
  • Working knowledge of SDTM, including define.xml, CDASH, metadata and/or ADAM is an asset.

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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