Clinical Data Standards Specialist

Geoff King at RBW Consulting is working with the worlds leading CRO in the recruitment of multiple Clinical Data Standards Specialists as they embark on an exciting new era of Data Science in the world of healthcare and drug discovery.

Supported by cutting edge technology and a management team of industry recognised experts this organisation gives you the opportunity to work at the forefront of the pharmaceutical industry by working on multiple global studies across phases I - IV.

The Principal Clinical Data Standards Specialist is responsible for the development, maintenance and implementation of Industry (CDISC and regulatory) compliant Clinical Data Standards, providing expert support to business users and teams on their use in line with the Clinical Data Standards strategy.

They provide expert support ensuring the development, implementation and timely availability of consistent, high quality Clinical Data Standards deliverables supporting the acquisition and tabulation and/or analysis and reporting of Clinical Trial data across global libraries including;

Data collection tools in EDC (CRFs, edits checks, derivations, core configurations) and data transfer specifications

Analysis data/TFL standards

Associated standard metadata, business rules and guidelines.

Key requirements:

• BS/BA/MS in computer science, management information systems, health sciences, statistics, or related field
• EDC systems (preferably including Medidata-Rave)
• Object Oriented Programming concepts
• Programming languages such as Visual Basic, SQL-PL/SQL and C# or Java preferable
• Good knowledge of SAS and other statistical programming languages/software (e.g. R)
• Strong understanding and knowledge of regulatory requirements and industry standards relevant to data management and statistical programming (including GCP, ICH)

A comprehensive job description is available upon request.

To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on +44 (0) 1293 584 300 and send your CV through to geoff.king@rbwconsulting.com or use the apply button on this page.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.