Lead Quality Control Auditor
hace 6 días
Job Overview
Responsible for quality control processes relating to customer deliverables for the Data Operations team.
Electronic Database Capture (EDC) system validation (InForm, Rave, IBM CD, Viedoc) based on Data Management/Programming specifications. The EDC components typically include eCRF design, EDC Administration/Configuration settings, Edit Checks, Data Integrations.
Understand and execute Quality Control validation template instructions / test plans to validate EDC system components against Data Management / Programming specifications, e.g. eCRFs, Edit Checks, Patient Profile reports, Ad Hoc reports, etc.
Work with team to revalidate the component(s) once Data Management and Programming update specifications (if needed) and make programming updates. The QCA will continue to work with Data Management and Programming to support the validation task through cycles of rework/revalidation until the component passes validation.
Review and assure detailed and quality documentation practices adhered to for the Quality Control validation documentation.
Assure QC documentation for each project are audit ready and uploaded to eTMF per the IQVIA Biotech SOPs. Support customer and regulatory audits.
Assist with management of QC resourcing and Sponsor deliverable timelines. Assist with the evaluation of quality control processes.
Assure process compliance with all regulatory and IQVIA Biotech SOPs.
Secondarily responsible for oversight of a selected group of projects and QC Auditors. Coordinate project deliverables with QC leads and QC manager.
Mentor on quality processes and advise on documentation.
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