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Snr Manager- Clinical Auditing

Edison-New Brunswick Metro Area, NJ

Posted: 03/27/2018 Job Type: Clinical Job Number: JN -032018-21245
  • Minimum of BA/BS degree in relevant discipline or equivalent/relevant work experience
  • Minimum 5 years of clinical quality assurance auditing and 5 years of work experience in clinical research and/or a GCP-related quality assurance environment
  • Assess/plan and/or perform GCP audits of clinical investigator sites, vendors, internal systems/processes, and clinical documents
  • Lead/participate in Health Authority GCP inspections
  • Lead/contribute to HA Inspection dossier preparation and document compilation/QC
  • Assess/review audit report responses and ensure that corrective and preventative action (CAPA) plans adequately address findings and root causes, including effectiveness checks where appropriate
  • Review/evaluate and maintain/track CAPAs and follow-up with stakeholders to ensure actions are completed
  • Lead/perform for cause audits or other high profile audits, projects and/or special investigations to evaluate noncompliance, root cause identification, and report results to leadership
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