Director of Clinical Trials Quality

The Director of Clinical Trials Quality at University of Wisconsin-Madison is responsible for the direction and leadership of operational, financial, programmatic and personnel activities for Clinical Trials Quality. This includes establishing, meeting and continuously monitoring the goals and objectives while maintaining alignment with the strategic goals and objectives set by the organization. While the range of duties and responsibilities is broad and varied, the position's major responsibility is directing the day-to-day operations, and human resource management. This position works closely with a variety of stakeholders, coordinating the activities of clinical research quality across the enterprise. Additionally, this position is a key member of the Clinical Trials Leadership team and will work to lead initiatives related to clinical trials accreditation.

The Director of Clinical Trials Quality systematically monitors performance, and in partnership with other clinical research leaders, develops strategic initiatives to improve quality. The Director of Clinical Trials Quality directs teams responsible for environmental scanning, maintaining document systems, tracking corrective actions, leading quality improvement activities and supporting auditing and monitoring both internally and by external organizations. This position is tasked with continuously monitoring regulations and accreditation requirements as they relate to clinical research and assisting in the identification of systems issues that impact clinical research. Director of Clinical Trials Quality assures compliance with applicable regulatory standards and state and federal laws governing research and is responsible for assuring organizational readiness for accreditation and certification surveys.

The Director of Clinical Trials Quality will report directly to the Chief Clinical Research Officer and will build and maintain strong partnerships with the UW Health Quality Team.

Qualifications: Skills

-Certification as a lead auditor
-LEAN or Six-Sigma training

Qualifications: Experience

-10 years of experience in a Quality Assurance or Quality Management position
-5 years of progressive management experience
-Experience with hosting FDA or federal agency audits
-Experience as a lead auditor

-Experience in pharmaceutical or device industry

Qualifications: Education
Master's degree
Application Instructions

Please click "Apply Now" to start the application process here:

You will be required to submit a cover letter and resume for consideration. Your cover letter should highlight your experience and skills as they relate to the listed qualifications for maximum consideration. This application will also require submission of three professional references, including your current or most recent supervisor. References will not be contacted without advance notice.

Questions about the application process may be directed to Kim Mcfarlane at or 608-263-1130.

The deadline to apply for this position is April 1, 2020 at 11:55pm CST.

Job Family
Job Type

Madison, WI
United States

Last modified
Wednesday, January 6, 2021 - 02:00