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.

The Role:

• Assist in the development, implementation and maintenance of end to end data standards from data collection to regulatory submission. Develop and maintain the strategy for the continuing and future adoption of industry wide data standards. Govern change control, publication and communication of new and updated data standards. Serves as subject matter expert in industry clinical data standards development and related initiatives
• Maintains complete and in-depth understanding of all CDISC guidance documents and implementation guides, as well as FDA guidance and regulations regarding electronic submission of data. Keeps abreast of industry trends in data mapping, data management, standards compliance methodologies, metadata management and data warehousing
• Demonstrates extensive understanding of Clinical Data Acquisition Standards Harmonization (CDASH) and Study Data Tabulation Model (SDTM) standards and concepts. Able to critically review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards. Recognizes limitations of eCRF design and correct flaws proactively
• Demonstrates extensive understanding of SDTM, Standard Terminology and common coding dictionaries. Able to critically provide and review SDTM mapping details
• Demonstrates extensive knowledge of SDTM, and define.xml validation rules and able to appropriately interpret results from common validation tools.
• Responsible for the implementation, strategy and configuration of the Metadata Repository used to manage libraries of CDISC related metadata, terminology and other related standards.
• Develop, implement and execute data standards policies, procedures, and practices
• Effectively and persuasively presents data standards concepts, assessment of risks and logical arguments to data operations staff, statistical programmers, and statisticians to ensure that the data standards have been applied accurately and completely throughout the process of collecting, conversion and submission of clinical data

To be successful in the role, you will have:

Basic Qualifications:

• At least 10 years of experience in clinical data management or statistical programming within a pharmaceutical, biotech, CRO or regulatory agency
• Subject Matter Expert (SME) for at least one CDISC foundational standard (i.e. CDASH, SDTM, etc) and well versed in industry trends impacting clinical data standards
• Working knowledge of the pharmaceutical drug development process, clinical research, and clinical trial study design
• Clear understanding of regulatory requirements for study data submission and regulatory compliance
• Solid understanding of medical concepts and terminology
• Leading clinical data management activities for startup of a protocol which include protocol review, gathering data collection requirements for eCRFs, eCOA and eDT, implementation and adherence of data collection standards, and database design support within clinical data management systems
• Familiarity with using at least one EDC system (e.g., Medidata Rave, InForm, Veeva, etc)
• Champions the development and use of standards
• Experience in managing CDISC compliant Data Standards, using CDASH standards and controlled terminologies at a minimum
• Strong cross-functional leadership skills to implement data standards in different situations
• Ability to problem-solve, think strategically and develop new approaches and processes
• Proven ability to work independently, take initiative and complete tasks to deadlines
• Good attention to detail
• Good verbal and written communication skills
• Good analytical skills
• Good computer skills
• Ability to collaborate and work in a cross-functional team environment
• Good organizational, planning and time management skills

Ideal Qualifications:

Any of the following characteristics would be a plus:

• Minimum 1 year of data analytics, data standards management, data governance, and/or programming experience
• Strong working knowledge of SDTM and the creation of data mapping specifications and annotated CRFs
• Experience required to challenge and improve the processes around data standards
• Understanding of database concepts, clinical data structures, relational database structures, and data exchange
• Demonstrated knowledge of metadata management
• Experience with Metadata Repository (MDR)
• Deep understanding of laboratory data
• Deep understanding of Pharmacogenomics (PGx) data

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 through the form below.

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