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SR. IxRS Lifecycle Support Specialist ( remote)

  • Global Channel Management, Inc.
  • 01/12/20
  • Irvine, CA
  • 92612
  • $56 / Hourly
  • Full-Time
SR. IxRS Lifecycle Support Specialist needs 5 7 years working with IxRS vendors
SR. IxRS Lifecycle Support Specialist requires:
Previous exposure to IxRS, Development or Use, is mandatory.
System validation and knowledge and understanding of regulatory guidelines for the use of computer systems in clinical trials, is expected.

SR. IxRS Lifecycle Support Specialist duties:
support IxRS Leads in implementing, maintaining and decommissioning systems provided by third party vendors (e.g. Interactive Response Technology (IRT) in context of multiple clinical research projects.
the supervision of IxRS leads, the specialist will be responsible , among other administrative tasks, to support the creation of documentation (i.e: User requirements, System specifications, Validation Plans, Test scripts, Change orders, decommissioning material) produced during data capture systems lifecycles, through the use of standardized documents and coordination with other functional groups representatives (Global Clinical Trial Management (GCTM), Global Clinical Supplies Management (GCSM), Statistical Sciences, Global Site Management Operations (GSMO), Quality Assurance, Clinical Pharmacology/Development, and Medical Safety staff).
The specialist is expected to be skilled in technical writing and technical documentation in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all policies, and procedures.

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