LIMS Business Technical AnalystCarlsbad, CA
Axians redtoo recently brought its almost 30 years of experience in IT and consulting solutions to the Axians family. As both strategic advisors and a full-service IT provider, our customers' core businesses benefit through our optimization of their business processes and effectively implementing their technology investment.
We are seeking a LIMS Business Technical Analyst to join our fast growing and dynamic global IT consulting company.
Configure and enhance the Laboratory Information Management System (LIMS) application to meet departmental needs. Develop and deliver related reports. Aid in creating the detailed IT solution/service design, based on user requirements, to meet quality and performance requirements and technical constraints. Translate high-level design and business requirements into system solutions and implement in alignment with the design and architectural standards, while meeting quality, performance and security requirements.
- Configure LIMS to meet end-user needs and those of the clinical trial partners. Work in conjunction with IT Team to identify and determine operational objectives/system functionality. Gather and/or write specifications, design workflow charts and diagrams, system capabilities, and identify and develop solutions to meet business needs.
- Develop and implement enhancements as needed.
- Maintain LIMS to keep current with departmental requirements and change requests.
- Ensure on-going system compliance with established GCLP and CLIA standards.
- Recommend and maintain system controls and protocols. Develop and maintain procedures and documentation as needed including writing technical and validation documents like URS, IQ’s, OQ, and SOP.
- Participate in training of super-users and trouble shoot any LIMS related issues.
- Participate in producing technical reports as requested.
- Collect, analyze and summarize information and trends.
- Create the detailed process designs necessary and operate the software/service on a day-to-day basis.
- Ensure designs produced adhere to architectural roadmap and support the development, execution and operations of software/service.
- Ensure that detailed designs adhere to solution architecture design (i.e. high-level conceptual design) and are traceable to functional as well as non-functional requirements in functional specification.
- Ensure the overall user experience is considered when designing new solutions and services.
- Develop system designs that adhere to high level conceptual design and are traceable to functional as well as non-functional requirements in projects/enhancements.
- Ensure designs produced adhere to architectural roadmap and support the development, execution and operations of solutions.
- Deliver design solutions in line with system design standards.
- Ensure that solutions meet requirements outlined in the architecture handbook.
- Perform scoping for projects/enhancements, propose solutions for key gaps and align with IT project teams.
- Ensure that developed solutions are peer reviewed, formally documented, and signed off by business.
- Initiate solution testing to ensure these meet quality standards.
- Follow standardized design and development processes to enable cost effective delivery.
- Highlight/identify gaps in existing functionality.
- Develop comprehensive requirement specifications.
- Ensure consistency and traceability between user requirements, functional specifications and testing & validation. Support validation and testing (OQ, PQ, UAT...).
- Solve business process / application challenges, by diagnosing & resolving unique, nonrecurring problems associated with hardware, software, operating systems, network & access issues related to LIMS.
- Related scientific background.
- Related experience with software maintenance and documentation, requirements analysis, data analysis.
- Knowledge of use of LIMS and laboratory functions to ensure system functionality meets user needs.
- Minimum of five (5) years total relevant experience.
- Minimum of two (2) years’ experience with clinical trial related data management and lab-related software systems, including data analysis and reporting preferred.
- Demonstrated knowledge and understanding of laboratory functions and processes.
- Experience and understanding of Clinical Laboratory techniques.
- Demonstrated problem-solving skills.
- Excellent written, verbal and interpersonal communication skills. Ability to communicate clearly and concisely with all levels of staff. Ability to write clear documentation.
- Demonstrated success in working independently and in a team environment.
- Degree in Biological Sciences or related scientific discipline a plus.
Competitive salary and benefits packages