LIMS Project Manager

LIMS Project Manager – Qualifications

Experience

• 5–10 years of project management experience in laboratory, pharmaceutical, biotech, healthcare, CRO, or related regulated environments.
• Direct experience implementing, migrating, or supporting LIMS platforms (e.g., LabWare, STARLIMS, LabVantage, Thermo SampleManager).
• Experience working with laboratory operations, scientists, QA/Compliance, IT, and external vendors.
• Strong understanding of laboratory workflows, sample lifecycle, data integrity (ALCOA ), and regulatory standards (CLIA, CAP, GxP, FDA 21 CFR Part 11).

Skills

• Strong project planning, prioritization, and scheduling skills.
• Excellent communication and stakeholder‑management capabilities.
• Ability to translate technical LIMS requirements into clear project tasks.
• Experience with change management and user training.
• Familiarity with system validation, UAT coordination, and documentation.
• Understanding of API integrations, instrument connectivity, and data migration processes.

LIMS Project Manager – Core Duties & Responsibilities

Project Leadership & Oversight

• Lead and manage the end‑to‑end LIMS migration project (planning, execution, monitoring, closure).
• Develop and maintain project plans, timelines, budgets, risk logs, and communication dashboards.
• Coordinate across laboratories, IT, QA, vendors, and external implementation partners.

Stakeholder & Cross‑Functional Collaboration

• Serve as the primary liaison between laboratory staff and LIMS vendors.
• Facilitate requirement‑gathering workshops, workflow mapping, and design sessions.
• Manage expectations, address concerns, and ensure strong alignment across teams.

LIMS Implementation & Migration Activities

• Oversee data migration strategy, mapping, cleansing, validation, and reconciliation.
• Support lab workflow redesign to fit new LIMS functionality.
• Ensure instrument integration and interface development are properly planned and executed.
• Coordinate configuration, customization, and system enhancements with the vendor.

Compliance, Validation & Documentation

• Ensure all project activities meet regulatory and quality standards.
• Oversee creation and approval of URS, FRS, configuration documents, validation plans, and SOP updates.
• Manage test cycles: system testing, integration testing, and UAT.

Change Management & Training

• Develop training plans with vendors and internal teams.
• Support end‑users with onboarding, documentation, job aids, and hands‑on training.
• Drive adoption and minimize disruption to lab operations.

Risk Management & Continuous Monitoring

• Identify, track, and mitigate project risks, issues, and dependencies.
• Monitor metrics, migration progress, and post‑go‑live system performance.
• Provide regular project updates to leadership.

Post‑Deployment Support

• Oversee go‑live stabilization activities.
• Transition support from project mode to long‑term operational ownership.
• Identify optimization opportunities for future phases.