Research Clinical Quality Manager

Clinical OperationsClinical OperationsFull TimeRemoteSeniorTeam 10,001+Since 1833H1B SponsorCompany SiteLinkedIn

Location

Tennessee

Posted

6 days ago

Salary

0

Seniority

Senior

Bachelor Degree3 yrs expEnglishGoogle Cloud Platform

Job Description

Research Clinical Quality Manager

McKesson

• 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

Job 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

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