Job Posting: Clinical Quality Program Manager

Salary Range:$95,000.00 To $130,000.00 Annually

The Clinical Quality Program Manager of the Minneapolis Heart Institute Foundation (MHIF) provides vision and leadership for a high quality, world-class clinical research. The Clinical Quality Program Manager is responsible for ensuring quality deliverables are produced within MHIF. This role will develop, maintain, supervise clinical quality initiatives of the MHIF Imaging Core Lab and collaborate with the Sponsored Clinical Trials team. This role will ensure compliance and continuous quality improvement of CIRC and Core Lab services and provide work direction for cross-functional or matrix teams, as appropriate. The role will provide leadership across MHIF to implement and ensure compliance with relevant SOPs and regulations. The role will serve as a strong research mentor to MHIF staff, physicians from Minneapolis Heart Institute, and partners outside the organization.

Primary Responsibilities:

Clinical Research and Imaging Core Lab Quality

Provide leadership in defining and implementing clinical quality initiatives. Initiatives include audit readiness, learning management system implementation, and day to day mentorship of research and imaging Core Lab personnel. May include identification and implementation of tools and processes to support clinical quality.
Responsible for development, maintenance, ensuring compliance to, and revisions to the MHIF Imaging Core Lab Quality Manual and Standard Operating Procedures (SOPs).
Responsible for ensuring all Core Lab staff are trained and qualified, and that documentation of training and qualification is documented and maintained.
Responsible for facilitating and hosting sponsor Core Lab audits and regulatory body inspections.
Responsible for ensuring disaster recovery and business continuity processes for the Core Lab are established and followed.
Ensure processes and procedures used to collect and process imaging data conform to all applicable standards to include ICH GCP, HIPAA, applicable FDA regulations and ISO standards.
Benchmark other Core Labs and develop plans to continue to keep the MHIF Core Lab at a progressive level as one of the best in the US.
Develop Core Lab QC/QA activities at regular time intervals.
Ensure that proficiency-testing requirements and procedures are consistent with contemporary practices and guidelines. Ensure that the laboratory maintains compliance with regulations as well as MHIF and Allina policies and procedures.
Responsible for collaboration with Sponsored Clinical Trials team to update and build consistency across MHIF SOPs. May also collaborate with Investigator Initiated Research team to support SOP development and revision.
Responsible for collaboration with Sponsored Clinical Trials team to implement the Sponsored Clinical Trial Quality Assurance program.
Create an effective partnership MHIF leaders of Regulatory and Compliance to ensure adherence with quality assurance and regulatory standards.
Ensure documentation is retained for all training and meetings within the lab structure.
Establish processes to document quality and productivity metrics of the Core Lab.
Foster an environment of collaboration among MHIF staff, physicians, and investigators. Collaborate with key functions, including Research Operations, Compliance, Quality and Regulatory, and Science Center leaders for an integrated program.

Key Qualifications for Consideration:

Previous professional experience in a clinical quality role in a regulated work environment
Academic and/or industry experience in research and development in the areas of cardiovascular physiology, medical imaging, preclinical/clinical research
Experience with vendor qualification audits and regulatory agency audits
Effective oral and written communication skills
Organizational skills such as leadership, teamwork, time management, planning, scheduling and resource coordination.
10+ years of medical research experience in FDA regulated environment
Proficient in ICH GCP, FDA regulations and ISO standards 14155 and 13485
Leadership or influence management experience

Total Rewards

The compensation range for this role takes into consideration a variety of factors including but not limited to skill sets; experience and training; licensure and certifications; internal equity; and other business and organizational needs. It is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are determined on the facts and circumstances of each case. The current range is $95,000 to $130,000.

In addition to salary, MHIF also offers a comprehensive benefits package for employees working 20 hours per week or more including medical, dental, life, and short- and long-term disability insurance, employer contributions toward a health savings account (if applicable), 401(k) with employer match and contribution, paid time off, paid parental leave, tuition reimbursement, paid volunteer time, and 10 paid holidays annually.

Apply to join our talented 100+ person team:

Apply Here

Minneapolis Heart Institute Foundation is an EEO/Affirmative Action employer.

Date posted: February 10, 2025