Research Clinical Quality Manager

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🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

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McKesson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1833

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare Insurance • Pharmaceuticals • Biotechnology

McKesson is a diversified healthcare leader specializing in pharmaceutical distribution, medical supplies, and healthcare services. Their solutions facilitate patients' access to life-changing therapies, support efficient operations for pharmacies, health systems, and clinics, and address critical issues such as drug shortages through a resilient supply chain. McKesson provides comprehensive services such as pharmacy management software, consulting, and technology solutions for specialty practices, focusing on improving health outcomes and advancing the pharmaceutical industry. They work closely with biopharma companies to enhance medication access, adherence, and commercialization while supporting oncology and biopharma practices through data-driven insights and real-world evidence.

📋 Description

• Responsible for implementing the quality assurance program • Managing and performing consult/support visits at investigative sites • Assisting with onsite external audits and inspections • Providing routine quality support for assigned investigative sites • Develops and maintains effective relationships with investigative sites and other SCRI departments and colleagues • Monitors and modifies policies and procedures • Utilizes quality tools that assess the quality indicators of study operations • Monitors quality indicators for all sites using Risk-Based approach and within framework of QBD – Quality by Design - and prioritizes quality indicators depending on severity/urgency • Identifies areas of deficiency in quality and reports those deficiencies to SC Directors and other appropriate colleagues • Assists the business in development and modification of process documents • Assists with preparation and hosting of external audits • Assists research staff in maintaining regulatory compliance • Performs process / focused audits (as needed) of research sites utilizing research audit tools to ensure quality and reports audit findings to the appropriate leadership • Ensures timely and appropriate follow-up in areas of deficiency • Communicates observations and deficiencies to the Site Director / Manager and study PI, as appropriate • Assists sites with Root Cause analysis and responses to external audits and CAPAs • Maintains records of audits and reports • Communicates with monitors and auditors of clinical trials, as needed • Educates staff in quality improvement methods and industry trends

🎯 Requirements

• Bachelor’s Degree required, Master’s Degree preferred • Minimum 3 years’ work experience in Quality Assurance, Quality Management, or Quality Auditing preferably in a clinical research, healthcare or life sciences field • Expertise in GCP, FDA and other applicable regulations in a risk-based environment

🏖️ Benefits

• Comprehensive benefits to support physical, mental, and financial well-being