Senior Principal Clinical Data Standards Consultant

Senior 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.

Overview:

A Clinical Data Standards Consultant is responsible for supporting the operational staff in the use of CDISC Standards, Sponsor Specific Standards, or ICON 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.

Responsibilities:

• Serve on Sponsor Standards and Technology Leadership teams.

• Consult with clients on sponsor-specific CDISC centric implementation projects.

• Participate in industry groups focused on the development of standards related initiatives (e.g. CDISC, PhUSE etc.).

• Author, maintain, implement, and report status for Standards Related Project Plans.

• Responsible for the implementation, strategy, and configuration of a metadata repository used to manage libraries of CDISC related metadata, terminology and related standards.

• Mentor Clinical Data Standards Consultants. • Lead Subject Matter Expert teams on topics relevant to standards.

• Identify areas for process improvement which may increase productivity, quality and / or compliance of deliverables in the areas from data collections through analysis and reporting.

• Participate in the analysis of metrics and in creating recommendations to the management teams on process improvements together with the Director of Global Data Standards.

Qualifications:

•  Minimum of 5 years+ of experience in industry in a role demonstrating knowledge of standards used by biometrics.

• An undergraduate degree or international equivalent from an accredited institution

• Demonstrated expertise in CDISC ADaM standards and associated controlled terminology with experience in the programming of analysis displays (e.g. tables, figures and listings).

• Excellent communication skills with demonstrated leadership ability.

• Demonstrated ability to plan, supervise, implement and monitor library management processes.

• Demonstrated successful client interactions in library management of client-specific standards, business development and consultancy with internal and external clients.

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.

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