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16 days old

Core Laboratory Operations Manager

Kelly Services
Minneapolis, MN 55405
Kelly Scientific is seeking an **experienced laboratory manager** to join one of our partners for an exciting **direct-hire** opportunity. This role will function to oversee the Cardiovascular Imaging Research Center (CIRC) and to help develop, expand, and maintain a high-quality, world-class imaging core lab.


MAIN FUNCTIONS


+ This high-impact role will function to develop, maintain, and supervise operations, while 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.


RESPONSIBILITIES


+ 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


REQUIREMENTS


+ BS degree in biomedical engineering or related disciplines

+ Masters degree or PhD **_preferred_**

+ 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.


JOB DETAILS


+ Job Type: Direct-Hire with company

+ Location: Minneapolis, MN

+ Pay Rate: dependent on experience


** For immediate consideration please send your resume to kerin.cahill@kellyscientific.com or book an interview directly on my calendar https://calendly.com/kerc995 **


\#P1


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-07-27 Expires: 2022-08-27

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Core Laboratory Operations Manager

Kelly Services
Minneapolis, MN 55405

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