LIMS Business Technical Analyst

• 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.