Subject Matter Expert (SME) – Laboratory Informatics & LIMS- Remote
About this role
Job Summary
Subject Matter Expert (SME) – Laboratory Informatics & LIMS- Remote
Experience: 10–15+ Years
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.
- Interviews: Video interviews.
- Docs required: ID proof will be required.
- Availability: Candidates able to join immediately are preferred
Originally posted on Himalayas