Research Clinical Quality Manager

McKesson

Research Quality Manager responsible for implementing quality assurance in clinical trials. Leading consult visits, audits, and ensuring compliance in oncology research.

Posted 7/10/2026full-timeRemote • Tennessee • 🇺🇸 United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance and Quality Management within clinical research, ensuring compliance with GCP and FDA regulations. Proficient in utilizing quality tools and conducting audits to maintain high standards of quality across investigative sites.

Highest-signal resume keywords

Quality Assurance Program ImplementationGCP ExpertiseRisk-Based Quality MonitoringRegulatory Compliance MaintenanceProcess Document Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceQuality ManagementQuality AuditingRisk-Based ApproachRoot Cause AnalysisAudit ToolsQuality Improvement MethodsPolicy ModificationDeficiency ReportingClinical Trial Monitoring

Soft Skills

Effective Relationship BuildingCommunication SkillsCollaborationProblem SolvingEducating Staff

Industry Keywords

Clinical ResearchHealthcareLife SciencesFDA RegulationsGCP ComplianceQuality by DesignExternal AuditsInvestigative SitesCAPAQuality Indicators

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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