Find a Better Way...
...to use your skills and experience.
This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way.
...to improve the lives of others.
Headquartered in Kobe, Japan, Sysmex Corp. is renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems. We apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.
Sysmex Inostics, a subsidiary of Sysmex Corp. is a molecular diagnostics company that is a pioneer in blood-based cell-free tumor DNA testing in oncology. Our highly sensitive OncoBEAM™ and SafeSEQ technologies can detect minute amounts of mutant DNA circulating in the bloodstream. With these technologies we support clinical researchers and oncologists with therapy selection and monitoring of response, recurrence as well as resistance.
...to build a promising future.
We currently have a great opportunity available for a Data Management and LIMS Specialist. The Specialist, Data Management and LIMS is responsible for developing, maintaining, and continually improving automated systems to support the processing of clinical laboratory samples and test data. As the local technical expert on computerized systems for a multi-site laboratory, this position is responsible for on-site data management and system interfaces as well as the development, implementation, and administration of the LIMS. He/she will reformat and transfer clinical study data according to study specific data transfer agreements and maintain associated documentation to ensure regulatory compliance. He/she will provide technical assistance and training to department personnel in the use of personal computers, standard software packages, and on-line information systems
Essential Duties and Responsibilities:
1. Support the development and implementation of a LIS/LIMS into the clinical laboratory, including configuration and programming, system validation (GAMP), SOP development, end-user training and site administration.
2. Lead and/or assist projects to evaluate, improve, implement and validate computerized systems as part of the clinical testing platform. These duties include writing protocols, reports, and compiling data and attachments into validation packages to meet regulatory/accreditation requirements according to CLIA/GCP/ISO. Ensure the integrity of data systems through trouble shooting, configuration and change management, as part of life cycle management.
3. Manage clinical research data including reformatting of data according to customer specification and established SOPs. Maintain the associated documentation to ensure regulatory compliance.
4. Evaluate existing data management processes and technologies, and suggest revisions to increase productivity and efficiency.
5. Support, maintain, and improve LIMS and its associated databases for data capturing and management in an integrated biomedical research environment
6. Create, update and maintain system documentation
7. Maintain knowledge of Data management and IT fields, analyze the abilities of tools and technologies and compare with the needs of the business, recommend potential solutions to managers within the business.
8. Lead and coordinate technical issue investigations and manage technology resolution implementations
9. Support laboratory IT system as necessary
10. Other duties as assigned
• Bachelor’s degree in biological, physical, engineering, computer science or closely related field plus 5 years relevant experience or Master’s degree in biological, physical, engineering, computer science or closely related field plus 2 years relevant experience. Previous experience in a regulated environment (e.g. ISO, CLIA,QSR, GC/LP or GMP) required.
• Working knowledge of MS windows operating system
• Knowledge in Excel, VBA, SQL, Basic
• Basic understanding of molecular biology techniques, especially PCR and NGS.
• Knowledge of computerized system validations (i.e. GAMP) and industry standards/regulations on data integrity (i.e. 21 CFR part 11)
• Experience with configuring, administering, and troubleshooting LIS/LIMS
• Experience with robotic liquid handling systems preferred
• Biotech, pharmaceutical, lab automation providers, or clinical-laboratory experience is highly desirable
• Must be a resourceful and active problem solver with the willingness to learn new skills.
• Self-motivated; strong in self-study
• Ability to work as an individual as well as in a team environment
• Strong communication and interpersonal skills, ability to collaborate across disciplines
• Able to self-direct toward individual milestones as part of team projects
Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of sex, sexual orientation, gender identity, color, religion, national origin, disability, protected Veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.