Quality Assurance Manager (30784)

Company Conformance Statements

In the performance of their respective tasks and duties all employees are expected to conform to the following:

• Perform quality work within deadlines with or without direct supervision.
• Interact professionally with other employees, customers and suppliers.
• Work effectively as a team contributor on all assignments.
• Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations.
  
  

Position purpose

The Quality Assurance Manager ensures the compliance of research study conduction and the integrity of the data across all research sites nationwide.

Responsibilities/Duties/Functions/Tasks

• Manage and oversee quality assurance teams
• Design, implement and improve company quality review processes and standards
• Facilitates ongoing trainings for quality staff members
• Analyze quality data to find areas for growth and improvement and report quality data metrics to leadership
• Determine yearly internal audit scheduling alongside VP of Research
• Create reports to track quality progress across sites and studies
• Create strategies to improve quality across sites
• Evaluate quality events, deviations, and queries
• Oversees and tracks the timely development of source in collaboration with local site teams
• Ensures all source updates are completed in a timely manner
• Quality checks source prior to releasing to the operations team
• Ensures source documents are reviewed across all sites and studies on a regular and rotating basis
• Communicate any critical compliance risks noted from quality checks to senior management.
• Assume a lead role for the preparation, conduct, and responses to regulatory agency, sponsor or IRB audits
• Maintains SOPs and coordinates yearly reviews and updates as needed
• Works alongside local site leadership to ensure completion of all audit findings
• Owns CAPA process and supports CAPA initiation and completion
• Other duties as assigned
  
  

Qualifications

Qualifications

Education

• Bachelor’s Degree from an accredited university preferred
• Clinical Research Certification preferred
  
  

Experience

• Minimum of 3 years of Supervisory/Management experience required
• Minimum of 4 years of clinical research required
• Research audit/monitor experience preferred
  
  

Other Requirements: Travel within the United States required

Performance Requirements

• Knowledge of grammar, spelling, and punctuation.
• Skill in operating office equipment.
• Skill in answering the phone and responding to questions.
• Skill in time management, prioritization, and multitasking.
• Skill in writing and communicating effectively.
• Ability to work under pressure, communicate and present information.
• Ability to read, interpret, and apply clinic policies and procedures.
• Ability to identify problems, recommend solutions, organize and analyze information.
• Ability to multi-task, establish priorities, and coordinate work activities.
• Ability to competently use Microsoft Office, including Word, PowerPoint, Excel, and appropriate practice management software.
  
  

Equipment Operated: Standard office equipment including computers, fax machines, copiers, printers, telephones, etc.

Work Environment: Position is in a well-lighted medical office environment. Occasional evening and weekend work. Up to 50% in and out of state travel is required.

Physical Requirements: Must possess the physical and mental abilities to perform tasks such as sitting for 90 percent of the day; manual dexterity to operate office machines including computer and calculator; stooping, bending to handle files and supplies; and mobility to complete errands or deliveries. Stress can be triggered by multiple staff demands and deadlines.

Employee acknowledgement/date

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