Senior Principal Clinical Data Standards Consultant

at  Icon plc

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.

LOCATION: (home-based OR office-based)

• Any EMEA/EU or UK location considered.

OVERVIEW OF THE ROLE:

The Senior Principal Clinical Data Standards Consultant will develop and implement ICON data standards libraries for data collection and SDTM. They will provide internal and external consulting services on topics related to CDISC standards compliance and standards implementation. They will support sponsors on the development, implementation, maintenance, and governance of data standards content.

• Develop and deliver training for both internal teams and for external sponsors on CDISC standards related topics
• Support the development and maintenance of technologies used for the implementation of data standards
• Provide sponsors with expert reviews of regulatory submission data packages for compliance with required data standards and submission readiness
• Lead standards governance team meetings and provide standards input as necessary
• May perform expert reviews of study artifacts (i.e. eCRFs, programming specifications, datasets and define.xml files etc.)
• Participate in the recruitment, interviewing, and mentoring of new team members
• Support business development in securing new business
• Lead subject-level SME teams
• Medium to large portfolio oversight of functional project teams and or projects of a complex nature.
• Contribute to development of initiatives for the department, possibly as project lead being responsible for other team members in a team lead role, but not as a line manager
• Lead others to solve complex problems while using sophisticated analytical thought to exercise judgement and identify innovative solutions
• Significantly impact the achievement of operational, project, or department objectives and ensures quality standards are achieved
• Travel (approximately 5%) domestic and/or international