Clinical Audit Manager

1 week ago


Denver, Colorado, United States Professional Case Management Full time
About the Role

Professional Case Management is seeking a highly skilled Clinical Audit Manager to join our team. As a Clinical Audit Manager, you will be responsible for managing and coordinating external audits, as well as remediation of potential corrective and preventive actions (CAPAs).

Key Responsibilities
  • Host and manage third-party audits of PCM TRIALS
  • Lead and coordinate the remediation of CAPAs (Corrective and Preventive Actions) resulting from third-party audits
  • Lead and/or assist activities in the areas of Internal Quality Audits, CAPA, Quality Management Reviews, and Quality Audits
  • Work cooperatively with the Quality Team to ensure all documentation and processes adhere to PCM TRIALS Quality Management System, GCP/ICH, and other related standard operating procedures and policies
  • Support PCM TRIALS staff toward the successful completion of incoming RFIs (requests for information), questionnaires, and other related requests
  • Develop and maintain Standard Operating Procedures and assist in monitoring compliance with them
  • Develop positive working relationships with third-party auditors
  • Perform other related duties as assigned
Requirements
  • Three to five years of audit management and/or coordination experience, clinical project management, or clinical trial site management experience
  • Excellent interpersonal skills with the ability to build and maintain positive relationships with management, peers, and external partners
  • Ability to create, maintain, and manage long-term vendor partnerships
  • Displays strong problem-solving skills
  • Ability to maintain confidentiality and work independently in a fast-paced environment
  • Clinical research industry experience required
  • Bachelor's degree from an accredited four-year college or university required
  • Demonstrates ability to deliver projects on-time
  • Ability to work with global customers across all time zones
  • Travel 0-20%
Benefits
  • Medical
  • Dental
  • Vision
  • 401(k)
  • Company Paid Short Term Disability
  • Flexible Spending Account (FSA)
  • Health Savings Account (HSA)
  • Paid Time Off
  • Voluntary Benefits


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