Process improvement consultant
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.
-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)
*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.
Job published:about 2 months ago