SR. IxRS Lifecycle Support Specialist (remote) (Irvine, CA)

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SR. IxRS Lifecycle Support Specialist (remote)

s www.globalchannelmanagement.com jobs(at)globalchannelmanagment.comSR. 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.

17-05-2024 UNITED STATES, Irvine, CA
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