The Minneapolis Heart Institute Foundation® (MHIF) and its Cardiovascular Imaging Research Center (CIRC) is seeking a Core Lab Operations Manager to help develop, expand, and maintain a high-quality, world-class imaging core lab. Now in its 40th year, MHIF is one of the leading non-profit cardiovascular research and education institutions in the country. We exist to create a world without heart disease and our mission is to improve people’s lives through the highest quality cardiovascular research and education.
In this high impact role, you will be responsible for to developing, maintaining, supervising operations, and expanding functions of the Core Lab. This an opportunity to help build and shape the Core Lab by providing vision and leadership, and by further developing processes and procedures. This role is instrumental to imaging projects in numerous cardiovascular clinical arenas to help define strategies and methods by which the imaging Core Lab will operate. The Operations Manager will ensure compliance and continuous quality improvement and provide work direction for cross-functional teams.
This is a unique role for someone looking for the opportunity to make an impact by developing effective strategies and methods to run a compliant and efficient lab, to collaborate with scientific leaders across the imaging community, and to lead a talented team of Core Lab personnel in achieving organizational and departmental goals.
Imaging Core Lab Operations and Compliance
- Direct Management of Core Lab personnel
- Responsible for development, maintenance, ensuring compliance to, and revisions to the 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 audits and regulatory body inspections.
- Responsible for ensuring disaster recovery and business continuity processes for the Core Lab are established and followed.
- Oversight of non-scientific training and compliance of Core Lab staff, management the overall function of the MHIF Core Lab
- Continually ensure and participate in the development of innovative methods for image collection and collection of other associated data in collaboration with Information Technology (IT) program management, CIRC resources, and sponsors of new research projects.
- Participate in scientific discussions and translate scientific objectives into imaging core lab strategies and initiatives related to imaging clinical research being conducted by ongoing collaborative research programs.
- Lead imaging core lab endeavors to enhance image collection services to incorporate analytic tools and pipelines resulting in enrichment of the data archives and enhancing value to the research community.
- 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 are met.
- Lead efforts to promote activities of the imaging core laboratory to include publication of results, attending professional meetings, providing website content and other forums as appropriate.
- 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 QC/QA activities at regular time intervals. Ensure that all required QC/QA elements, regulatory and accreditation standards are met.
- Ensure that proficiency-testing requirements and procedures are consistent with contemporary lab practices and guidelines. Ensure that the laboratory maintains compliance with all federal, state, and inspecting agency regulations as well as MHIF and Allina policies and procedures.
- Secure technology for data storage, server activity and data archival.
- Maintain records for all training and meetings within the lab structure.
- Establish and track the quality and production metrics of the lab.
- Support efforts to secure funding through grants
Core Lab Management and Relationships
- Manage resource allocation and assignments of imaging scholars relating to project execution, educational meetings, and visitors.
- Create an effective partnership with the Sr. Director of Regulatory and Compliance, MHIF to ensure compliance with quality assurance, accreditation requirements and regulatory standards.
- 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.
This position formally reports to the MHIF Program Director, Valve Science Center with close interface with physician leaders. This individual collaborates with key staff within MHIF, a range of physicians from the Minneapolis Heart Institute, research scholars, and core lab customers.
- Previous experience in growing and maintaining a research core lab, or equivalent project/program development experience in a regulated work environment
- Academic, clinical and/or industry experience in research in the areas of cardiovascular physiology, medical imaging, algorithm development, biological modeling, preclinical/clinical research
- 10+ years of medical research experience in FDA regulated environment
- Leadership experience in providing work direction to professionals and optimizing their skills as well as being responsible for a team and organizational function
- Effective oral and written communication skills
- High attention to details to ensure accurate imaging analysis and compliance with quality procedures
- Proficient in ICH GCP, FDA regulations and ISO standards 14155 and 13485
- Organizational skills as they relate to personal leadership, teamwork, time management, planning, scheduling and resource training and coordination.
- Proficiency with various computer software applications, analysis, and exposure to DICOM data sets as it relates to the handling, storing, and transmitting information in medical imaging.
- Master’s degree or PhD, preferably in the areas of biomedical engineering or related disciplines of study
This job description represents the major functions of the position but is not intended to be all-inclusive.
Join our talented 80+ person team:
Minneapolis Heart Institute Foundation is an EEO/Affirmative Action employer.
Date posted: June 6, 2022