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Core Lab Operations Manager
  • Location: Minneapolis, MN
  • Type: Direct Hire
  • Job #15911
What's the first thing that pops into your head when you think of Minneapolis? Is it art? Minneapolis is a city that appreciates the arts, considering the amount of art museums that are there! You have the Frederick R. Weisman Art Museum, Minneapolis Institute of Arts, and Walker Art Center to name a few! Perhaps hiking is more your style? Restaurants? No matter what you're into, this city has something for everyone! 
 
You know what else Minneapolis has? Opportunities! Especially for those Core Lab Operations Managers who are looking to take the next step in their careers. If this suits your fancy, then you should keep reading! 
 

Lighthouse Lab Services is representing a top-tier research facility in the Minneapolis area that is looking for a Core Lab Operations Manager to join their awesome team of employees! If this is something you think you'd be interested in, then keep on reading (and not because I'm such a good writer, that's an added perk): 
 
Key responsibilities for this position include, but are not limited to:
-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 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, facility 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 Core Lab at a progressive level.
-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 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
 
Basic Preferred Profile:.
-Master's Degree or PhD in BioMedical Engineering or related. 

-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 datasets as it relates to the handling, storing, and transmitting information in medical imaging.
-Previous experience working in the Medical Devices industry considered an added plus. 
 
Salary and Benefits: 
 
-Competitive Salary
-Stellar Benefits
-Relocation Assistance provided.
 

If you fit the above profile, we'd love to hear from you!
 
About Us:
 
At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 19 years of proven success placing job seekers in positions ranging from entry-level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.
 
It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Lighthouse Lab Services will provide reasonable accommodations for qualified individuals with disabilities.
 

Lighthouse Lab Services | 800-838-0602 | lighthouselabservices.com

#MP Job ID: 15911

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