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Interactive Response Technology Lead
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- The patients we serve are our number one priority and IGOT aims to employ the highest quality standards across our internal and vendor IRT solutions.
- The IRT Lead will be assigned when it is determined that an IRT system may be needed at the draft protocol stage.
- He or she will perform a preliminary protocol assessment with the Supply Chain Lead (SCL), Clinical Research Pharmacist (CRP) and clinical team members (e.g., clinician, biostatistician) to determine the most effective IRT strategy for clinical customer, investigator site, Global Clinical Supply, and ultimately for the patient.
- He or she will work to elicit additional protocol requirements from the clinical team, then partner with the IRT vendor to ensure the IRT system is programmed according to the protocol, test scripts are complete and accurate, and execute User Acceptance Testing (UAT) in order to successfully deploy the system into production.
- The IRT Lead will also partner with IGOT management for quality investigations, CAPA commitments and continuous improvements, SOP review and revision activities, support regulatory inspections, and limited duration teams where appropriate.
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