DIRECTOR OF CLINICAL TRIALS QUALITY

Location
Wisconsin, United States
Salary
Salary Not Specified
Posted
Mar 19, 2021
Employment Type
Full Time
Job no: 231697-LI
Work type: Staff-Full Time
Department: SMPH/CLINICAL RESEARCH
Location: Madison
Categories: Communications, Editing, Broadcasting, Media, Dean, Director, Executive, Environmental, Occupational Health and Safety, Health Care, Medical, Social Services, Management/Supervisory, Natural Resources, Environmental Sciences, Project Management, Quality, Risk Management and Compliance, Research, Scientific, Training, Employee Development



Position Summary:

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 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. 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 will report directly to the Chief Clinical Research Officer and will build and maintainstrong partnerships with the UW Health Quality Team.

The School of Medicine and Public Health has a deep and profound commitment to diversity both as an end in itself but, alsoas a valuable means for eliminating health disparities. As such, we strongly encourage applications from candidates whofoster and promote the values of diversity and inclusion.

Position Duties:

List of Duties

Institutional Statement on Diversity:

Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.

The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.

For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion

Degree and Area of Specialization:

Bachelor's degree required. Master's degree preferred

Minimum Years and Type of Relevant Work Experience:

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

Preferred:
-Experience in pharmaceutical or device industry
-Certification as a lead auditor/monitor
-LEAN or Six-Sigma training

License or Certificate:

Certification through SOCRA, ACRP, or QRM required.

Additional Information:

The successful applicant will be responsible for ensuring eligibility for employment in the United States on or before the effective date of the appointment.

Department(s):

A532700-MEDICAL SCHOOL/CLINICAL RESEARCH

Work Type:

Full Time: 100%

Appointment Type, Duration:

Ongoing/Renewable

Salary:

Minimum $101,841 ANNUAL (12 months)
Depending on Qualifications

Instructions to Applicants:

Please click "" to start the application process. 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.

Contact:

Kim Mcfarlane
kmmcfarlane@wisc.edu
608-263-1130
Relay Access (WTRS): 7-1-1 (out-of-state: TTY: 800.947.3529, STS: 800.833.7637) and above Phone number (See RELAY_SERVICE for further information. )





Official Title:

DIR, UNSPECIFIED (8)(M94DN)

Employment Class:

Limited

Job Number:

231697-LI

The University of Wisconsin is an Equal Opportunity and Affirmative Action Employer. We promote excellence through diversity and encourage all qualified individuals to apply.

If you need to request an accommodation because of a disability, you can find information about how to make a request at the following website: https://employeedisabilities.wisc.edu/disability-accommodation-information-for-applicants/

The University of Wisconsin-Madison is engaged in a Title and Total Compensation (TTC) Project to redesign job titles and compensation structures. As a result of the TTC project, official job titles on current job postings may change. Job duties and responsibilities will remain the same. For more information please visit: https://hr.wisc.edu/title-and-total-compensation-study/ .

Employment will require a criminal background check. It will also require you and your references to answer questions regarding sexual violence and sexual harassment.

The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7).

The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department .

Applications Open: Mar 19 2021 Central Daylight Time
Applications Close: Apr 16 2021 11:55 PM Central Daylight Time

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