Overview
LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.
We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.
Summary
The Lab Information Systems Analyst is responsible for configuring, developing, implementing, and maintaining clinical testing set up in laboratory information management system (LIMS) databases and/or interfaces between LIMS and Lab Information Systems (LIS). This role provides primary support, design, development, testing, debugging, installation, implementation, and modification of new or existing LIMS implementations and interface integrations. Analysts may be called on to participate in discussions and decisions, internal and external, related to study initiation and support. They will administer daily operational support and assist with the planning and implementation of software enhancements. They will apply expertise to provide inter-department consultation, training, documentation, guidance, and monitor applications and services to ensure quality standards are consistently met.

Required Skills

• Bachelor’s degree in Computer Science, Information Technology, or a related field.
• Demonstrated ability to draft precise requirements and effective validation documentation.
• Proven experience with healthcare integration.
• Mirth Connect experience preferred.
• Strong understanding of HL7 and other healthcare data standards.
• Proficiency in JavaScript and SQL.
• Experience with RESTful services and JSON.
• Experience with FDA 21CFR11/GCP.
• Excellent attention to detail and ability to adapt to changing environments and requirements, and customer service/client relationship management skills.
• Ability to adhere to established timelines, processes, and procedures.
• Self-motivation and ability to work well independently as well as using a collaborative team approach.
• Excellent organization, time management skills, communication, multitasking, and interpersonal skills.
• Excellent listening and verbal comprehension skills, including the ability to translate client needs to team members.
• Strong communication, planning and problem-solving skills.
• Ability to make quick but well-thought-out decisions.
• Proficiency in Microsoft Word, Excel, and database software

• Maintain the integrity and security of all data within data systems
• Collaborate with clinical laboratories in the design, build, and validation of all testing components.
• Design, develop, and implement HL7 interfaces using Mirth Connect.
• Create automated data workflow exchanges using HL7, FHIR, RESTful services, and JSON formatted data with external systems and applications.
• Perform message filtering, transformation, and routing.
• Develop and maintain real-time and batch interfaces for data exchange.
• Collaborate with partner labs and IT teams to gather requirements and ensure successful integration.
• Perform verification testing and validation documentation for clinical tests, panel builds, and integrations.
• Review and analyze data flow between internal applications and debugging to support clinical trials tests.
• Assist in debugging Health Level 7 (HL7) and other interface messages as appropriate.
• Collaborate with internal Integration Team to validate, monitor, and troubleshoot electronic interfaces and imports from Partner Laboratories.
• Troubleshoot and resolve issues related to data exchange and integration.
• Ensure compliance with healthcare standards such as HIPAA and HL7.
• Provide technical support to project team members; handle complex application features and technical designs and training to end-users and stakeholders.
• Implement solutions and/or redefine workflows to maximize the functionality of systems.
• Identify and improve business processes and support critical business strategies by assisting in LIMS development, implementation, and maintenance for clinical trials tests and integrations between systems.
• Keep validation documentation up to date per quality procedures.
• Provide LIMS or integration training for new and current employees as needed.
• Participate in regular meetings with LDS personnel to exchange progress reports.
• Maintain confidentiality of information in accordance with company policies and procedures.
• Perform additional tasks as required.
  Education and Experience
  Four-year college or university program certificate, three to four years related laboratory information system or integrations experience, or experience in the clinical laboratory and/or clinical trial industry and/or training, or equivalent combination of education and experience.

Required Skills

• Bachelor’s degree in Computer Science, Information Technology, or a related field.
• Demonstrated ability to draft precise requirements and effective validation documentation.
• Proven experience with healthcare integration.
• Mirth Connect experience preferred.
• Strong understanding of HL7 and other healthcare data standards.
• Proficiency in JavaScript and SQL.
• Experience with RESTful services and JSON.
• Experience with FDA 21CFR11/GCP.
• Excellent attention to detail and ability to adapt to changing environments and requirements, and customer service/client relationship management skills.
• Ability to adhere to established timelines, processes, and procedures.
• Self-motivation and ability to work well independently as well as using a collaborative team approach.
• Excellent organization, time management skills, communication, multitasking, and interpersonal skills.
• Excellent listening and verbal comprehension skills, including the ability to translate client needs to team members.
• Strong communication, planning and problem-solving skills.
• Ability to make quick but well-thought-out decisions.
• Proficiency in Microsoft Word, Excel, and database software.