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Process improvement consultant

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Process improvement consultant

Pharmaceuticals

Remote

Description

This is strategic role to help reduce complexities within the clinical standards process. You'll be helping to shape standards processes from regulatory requirements to submission within a global Pharma environment.

Role


-Optimize SDTM Transformation process, including Validation/QC strategy, macro development, spec templates, etc.
-Develop Treatment / Trial Design Definition process
-Shape SDTM Structure/Content Validation process (Pinnacle/CDISC CORE)
-Provide Input/content for training development (e.g. LOS/WBTs)




Experience

*You'll be experienced in clinical standards and shaping processes with a strong systems background
*You'll bring knowledge of SDTM and ADaM knowledge
*Define-XLM and SAS Programming best practice
*Strong stakeholder management and used to working with distributed global teams




This is a long-term engagement working remotely in either the UK or Europe. If based in the UK this will be outside of IR35.

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Job Details

  • Job Type:

    Contract
  • Rate:

    Negotiable
  • Job published:

    about 2 months ago
  • Reference:

    BBBH8702