Clinical Data Standards Lead
|Job Title:||Clinical Data Standards Lead|
|Location:||New Jersey, USA|
|Contact Name:||David Lawrence|
|Job Published:||April 08, 2019 11:10|
Our client is a global leading in the consumer healthcare market. They require a clinical standards consultant to join their team helping to develop, maintain and validate new standards. You will provide co-ordination and clear oversight within their clinical database systems both for existing and future plans particular within medical device market.
*Collaborate with the Clinical Data Management leadership teams including Programming and Biostatistics
*Define and document data and process standards aligning to CDISC/CDASH standards (including eCRF structure, variables, formats, site numbering, edit checks, etc)
*Provide in-house project support for creation, routing and approval of all system deliverables associated with clinical data standards
*Support the development and maintenance of global harmonised processes and procedures
*Support vendor evaluation, selection, contracting, and oversight activities for outsourced systems required to support clinical data standards
*Bachelor's degree in Statistics, Computer Science or related discipline
*5-7 years of system experience in clinical research within Medical Device or Pharma
*Proven experience with at least one clinical system (EDC, CTMS, eTMF and IxRS) is essential
*Experience with CDISC & STDM
This can be a remote role for the right candidate however some travel between Europe and North America will be required at short notice so you will need to be based in either region.