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United States
Work type
Remote
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The Integrations Test Analyst is responsible for the following:

  • Testing of Companies proprietary Integration solutions in support of the client’s study.
  • Collaborate with Integrations Leads to ensure integration builds are tested appropriately to deliver a high quality, validated integration to clients.
  • Responsible for operational testing required for integrations applications (initial build / post go live changes) as per 4G Clinical SOPs:
    • Responsible for integration level validation to ensure integration is developed, tested and deployed as per 4G Clinical SOPs.
    • Work with Integrations Leads to identify and understand integration customizations, if any, to ensure that a risk assessment can be properly conducted as per 4G Clinical SOPs and that the integrations testing strategy reflects this.
    • Develop study-specific integration validation plans, test strategies and test cases.
    • Execute integrations testing, following 4G Clinical SOPs.
  • Participate in client audits.

  • The position requires a minimum of 2 years’ experience in the clinical research field, particularly clinical supplies operations, RTSM/IRT (Interactive Response Technology) services delivery and eClinical systems implementation.
  • Knowledge of US FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GCP regulations, Electronic Records; Electronic Signatures regulation (21 CFR Part 11) and EU Annex 11, and associated regulatory guidance documents.
  • Software testing experience is a plus.
  • Experience with IRT/RTSM is preferred.
  • Experience working with agile development methodology is a plus.

Education and/or Certification Requirements

  • The candidate must possess at minimum a bachelor’s degree in a life sciences, supply chain management, or information technology field, or equivalent experience.

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