Lead Lab Informatics SME: LIMS, CDS & CTMS (Remote)

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

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