Clinical Audit Manager
1 week ago
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
- 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%
- 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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