What are the responsibilities and job description for the Operations Manager, Cardiovascular Imaging Research and Core Lab position at Minneapolis Heart Institute Foundation?
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.
The Operations Manager will provide vision and leadership for a high quality, world-class Center and Core Lab and is responsible for ensuring quality deliverables are produced within the Center. The role is responsible for developing, maintaining, supervising operations and expanding functions of the Core Lab. The Operations Manager will ensure compliance and continuous quality improvement of CIRC and Core Lab services and provide work direction for direct reports and cross-functional teams, as appropriate. The role will serve as a strong technical operational liaison to MHIF, Minneapolis Heart Institute physicians, and external partners.
Primary Responsibilities:
Imaging Core Lab Operations and Compliance
- Direct Management of Core Lab personnel
- Responsible for managing the execution of Imaging Core Lab services across a portfolio of clinical research trials
- 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 of the overall function of the MHIF Core Lab
- Continually ensure and participate in the development of innovative research processes in collaboration with Information Technology (IT) program management, CIRC resources, and sponsors of new research projects.
- 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.
- Support efforts to secure funding through grants and collaborations which will support continued development of the core lab capabilities consistent with the research needs of the community being served and the mission of the Minneapolis Heart Institute Foundation.
- Lead efforts to promote activities of the imaging core laboratory to include attending professional meetings, providing website content and other activities 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 Quality Control/Quality Assurance activities to be conducted at regular time intervals.
- 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.
- Create an effective partnership with MHIF leaders of Regulatory and Compliance.
- Secure technology for data storage, server activity and data archival.
- Establish and track the quality and production metrics of the lab.
Core Lab Management and Relationships
- Manage resource allocation and assignments of research personnel relating to project execution
- Foster an environment of collaboration among MHIF staff, physicians, and investigators. Collaborate with key functions, including Research Operations, Compliance, Quality and Regulatory, Finance, and Science Center leaders for an integrated program.
Key Qualifications for Consideration:
- Previous experience in establishing, growing and maintaining a research core lab, or equivalent experience in a regulated work environment
- Academic and/or industry experience in research and development in the areas of cardiovascular physiology, medical imaging, algorithm development, biological modeling, preclinical/clinical research
- Advanced degree preferred,
- Effective oral and written communication skills
- Organizational skills as they related to 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 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 $110,000 DOQ.
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.
Salary : $95,000 - $110,000
