Subject Matter Expert (SME) – Laboratory Informatics & LIMS

Lorven Technologies Inc.; United States; Remote; USD 180,000 - 280,000; Full time

Job summary

Lorven Technologies Inc. seeks an experienced Subject Matter Expert (SME) with 15+ years in Life Sciences, Healthcare IT, and laboratory informatics to lead LIMS, CDS, and CTMS initiatives.

You will guide program delivery, regulatory compliance, and transformation across global labs and trial operations. The ideal candidate brings domain leadership, regulatory knowledge, business process insight, and technical acumen to modernize lab informatics platforms and support digital transformation

Qualifications

• Over 10 years delivering Life Sciences and Healthcare IT programs.
• Experience with LIMS, CDS, CTMS/TMS, and laboratory informatics platforms.
• Deep understanding of laboratory workflows and data management.
• Regulatory compliance experience including GxP, GAMP 5, CSV/CSA, and 21 CFR Part 11.
• Strong stakeholder management, business analysis, and consulting skills.
• Experience working in global delivery and regulated environments.

Responsibilities

• Serve as the primary SME for LIMS and related laboratory workflows.
• Understand end-to-end clinical laboratory operations including sample lifecycle management and study management.
• Gather, analyze, and document business requirements from laboratory stakeholders and clinical operations teams.
• Support onboarding of new laboratories, regions, studies, and customers.
• Collaborate with stakeholders, laboratory teams, technology teams, vendors, and leadership to deliver business solutions.
• Translate business requirements into scalable, compliant system solutions.
• Manage risks, dependencies, issues, and mitigation plans to ensure delivery outcomes.
• Oversee data migration, system integration, release planning, change management, and deployment activities.
• Ensure compliance with GxP, GAMP 5, 21 CFR Part 11, data integrity, and validation requirements.
• Support validation activities including URS, FRS, IQ/OQ/PQ, traceability, audit readiness, CAPA, and change control processes.
• Drive continuous improvement, process optimization, and adoption of industry best practices.

Job description

Role: Subject Matter Expert (SME) – Laboratory Informatics & LIMS

Experience: 10-15+ Years

Location: Remote

Role Summary

Seeking an experienced Subject Matter Expert (SME) with 15+ years of experience in Life Sciences, Healthcare, Laboratory Informatics, and Clinical Research systems. The candidate will provide domain leadership for LIMS, CDS, Trial Management Systems, and related laboratory platforms, driving business transformation, system modernization, regulatory compliance, and successful program delivery.

The ideal candidate will combine domain expertise, regulatory knowledge, business process understanding, and technical acumen to drive successful delivery of laboratory informatics programs and digital transformation initiatives.

Key Responsibilities

• Serve as the primary SME for LIMS and associated laboratory workflows.
• Understand end-to-end clinical laboratory operations including sample lifecycle management, study management, test management, results processing, reporting, and data delivery.
• Gather, analyze, and document business requirements from laboratory stakeholders and clinical operations teams.
• Support onboarding of new laboratories, regions, studies, and customers.
• Collaborate with business stakeholders, laboratory teams, technology teams, vendors, and leadership to define and deliver business solutions.
• Analyze laboratory workflows and translate business requirements into scalable, compliant system solutions.
• Manage risks, dependencies, issues, and mitigation plans to ensure predictable delivery outcomes.
• Oversee data migration, system integration, release planning, change management, and deployment activities.
• Ensure compliance with GxP, GAMP 5, 21 CFR Part 11, data integrity, and validation requirements.
• Support validation activities including URS, FRS, IQ/OQ/PQ, traceability, audit readiness, CAPA, and change control processes.
• Drive continuous improvement, process optimization, and adoption of industry best practices.

Required Skills & Experience

• 10+ years of experience delivering Life Sciences and Healthcare IT programs.
• Strong expertise in:
• Laboratory Information Management Systems (LIMS)
• Chromatography Data Systems (CDS)
• Clinical Trial Management Systems (CTMS/TMS)
• Laboratory Informatics Platforms
• Clinical and Laboratory Operations
• Hands-on experience with system implementation, migration, upgrades, integrations, and support.
• Strong understanding of laboratory workflows, sample lifecycle management, study management, and data management.
• Experience with validation and compliance frameworks including GxP, GAMP 5, CSV/CSA, and 21 CFR Part 11.
• Knowledge of data migration, ETL processes, APIs, system integrations, and reporting solutions.
• Strong stakeholder management, business analysis, and consulting skills.
• Experience working in global delivery and regulated environments.

Preferred Qualifications

• Experience across pharmaceutical, biotechnology, CRO, diagnostics, or healthcare organizations.
• Exposure to cloud-based laboratory platforms, analytics, and AI-enabled solutions.
• PMP, CBAP, Agile/Scrum, or relevant Life Sciences certifications.
• Strong leadership, communication, presentation, and problem-solving skills