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ICON (formerly PRA Health Sciences)

Country: United Kingdom

Specific Location: Home-based – anywhere in Europe

Job Title: Senior Principal Clinical Data Standards Consultant

Type of Job: Permanent

Job Description:

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.

A Clinical Data Standards Consultant is responsible for supporting the operational staff in the use of CDISC Standards, Sponsor Specific Standards, or PRA Standards. They will develop tools to increase the efficiency, timeliness and quality of deliverables for data collection, tabulation, analysis and reporting. They will also define, and collect metrics about the use of standards. They will participate in the development of training of the operational staff in the areas of their expertise.

Develop, implement and maintain end-to-end data standards from data collection to regulatory submission.  
Function as the lead developer with responsibility in creating and maintaining libraries for use in designing, programming edit-check programs and custom reports.   
Leads in the enforcement and governance of library items.
Develop and maintain training and reference materials related to standards topics. 

An undergraduate degree or international equivalent from an accredited institution is required. 
5 to 8 years of experience in industry in a role demonstrating knowledge of standards used by biometrics.
Expertise in edit check programming and programming related to data management activities is required. 
Working knowledge of CDISC standards for data collection (CDASH) and tabulation (SDTM) and Controlled Terminology required.
Proficient in the programming of edit checks in Medidata RAVE or other comparable clinical data management systems.   
Experience programming custom functions and SAS based listings.
Excellent communication skills with demonstrated leadership ability. 

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.

Closing Date: December 1, 2021

Website/URL for further details: click here

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