Senior Global Clinical Auditor—New Jersey

Senior Global Clinical Auditor—New Jersey

December 9th, 2016 by

Senior Global Clinical Auditor—New Jersey

Tanner and Associates is recruiting a Senior Global Clinical Auditor for a Pharmaceutical company based out of New Jersey.


  • Conducts global GCP audits of clinical studies, Protocols, Medical Research Reports and suppliers
  • Assesses compliance of clinical investigations and internal processes
  • Manages clinical study site and supplier audit activities for key drug compounds on a regional and trans-regional basis.
  • Interacts with Study Managers to develop and refine audit plans
  • Interacts with Global Study Audit Manager to track and complete audit plan.
  • Develops audit tools, reviews draft of audit reports, and prepares and distributes the Study Audit Summary Report
  • Leads Global System Audit teams to develop, conduct, and report results to the Global Functional Heads.
  • Improves processes for Development & Compliance and Clinical Pharmacology audit metrics.
  • Leads regulatory inspection activities and serves as an inspection committee member
  • Provides interpretation and guidance for internal and external customers on clinical quality regulations/guidelines (FDA, ICH, EU, etc.)
  • Supports development and refinement of the Global Quality System by participating in SOP authorship.
  • Conducts training on the audit process for internal and external customers
  • 40-50% international travel


  • BS in biomedical science or equivalent with 8 years pharmaceutical industry experience; or, a MS in biomedical science or equivalent with 5 years of pharmaceutical industry experience.
  • Minimum of 5 years of clinical research experience and 2-3 years of GCP auditing experience.
  • Knowledge and experience of GCP requirements
  • Familiar with computerized clinical data collection systems and biomedical statistics
  • Proven project management skills including effective planning and organizational skills.
  • Must be willing to travel approximately 40-50% to North America, Latin America, Australia and elsewhere

Please send a CV and contact information to Jake Tanner at .  US candidates only please.


Jake Tanner

Tanner & Associates


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