Clinical Data Standard Consultant

A Principal Clinical Data Standards Consultant is responsible for supporting the operational staff in the use of ADaM and the define.xml capture for statistical analysis within the Medidata standard. 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.

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.

• 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 CDASH, SDTM standards and associated controlled terminology with a good understanding of CRF design concepts.

• Excellent communication skills with demonstrated leadership ability.