Principal Clinical Data Standards Consultant

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Responsible for the implementation of standard content in data collection tools regardless of the mechanism of collection.

This role will be driving this initiative, strong leadership and independent work style will be critical for the candidate

Example of standard content:

• Standard CRF Mock-ups
• Standard Questionnaires, Rating Scales and Clinical Outcome Assessments
• Standard Validation Rule Specifications
• Standard Integrations (e.g. with IWRS)
• Developing and implementing specifications
• Developing  a UAT plan and related test scripts for a set of forms
• Supporting the implementation of custom functions
• Developing data validation rules
• Expertise in RAVE, DTAs, Pinnacle 21 and CDISC Standards (SDTM, CDASH, controlled terminology and define.xml)

Final responsibility over:

• Correctness of annotated CRF meeting submission, scientific and operational requirements and guidelines
• Definition and maintenance of standard clinical data collection, data review and data delivery metadata
• Mapping and derivation metadata used for automating data flow from data collection tool (eCRF) to Data Review Model (DRM) and from DRM to SDTM
• Implementing standard content in the collection tools compliant to the industry standards and health authority regulations, meeting best computer system validation practices
• Correct testing  and QC of the collection tools

10 years of relevant experience

BS Degree in relevant field of study


Benefits of Working in ICON:

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.

At 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.

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, color, 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.