Principal Clinical Data Standards - REMOTE

Prinicpal Clinical Data Standards Consultant - Permanent - Remote

Proclinical are recruiting for a Principal Clinical Data Standards Consultant to join a global CRO. This role is on a permanent basis with the ability to work remotely from anywhere in the UK.

Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance.

Responsibilities:

• Develops and implements end-to-end data standards libraries from data collection to analysis
• Provides internal and external consulting services on topics related to CDISC standards compliance and standards implementation
• Supports sponsors on the development, implementation, maintenance and governance of data standards content
• Develops and delivers training for both internal teams and for external sponsors on CDISC standards related topics
• Supports the development and maintenance of technologies used for the implementation of data standards
• Participate in standards governance team meetings and provide standards input as assigned
• Provide input in the development of 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
• Participate in 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 subject-level SME teams
• 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

Key Skills and Requirements:

• Expert functional knowledge level of at least one area of standards.
• Business Expertise:
• Ability to apply expert knowledge of business challenges, and recommend best practices to improve products, processes or services to differentiate the business market. Develops standards content in area of expertise both internally and for sponsors. Provides guidance on standards implementation and compliance.
• Travel (approximately 15%) domestic and/or international
• Leadership:
• Contribute to development of initiatives for the departmental possibly as project lead being responsible for other team members in a team lead role
• May mentor more junior team members
• 12-15 years experience as a lead programmer/programming manager (ADaM, SDTM)
• Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated
• 12+ years of related experience in data collections standards or lead programming/programming in the clinical research industry
• Advanced knowledge of SDTM and ADaM standards and of regulatory submission requirements pertaining to tabulation and analysis data
• Experience with writing complex SAS programs and macros using the creation of SDTM, ADaM and TFL deliverables
• Ability to apply expert knowledge of business challenges, and recommend best practices to improve products, processes or services to differentiate the business market
• Bachelor's degree

If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at h.hennigan@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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