Senior IT Product Analyst

Job Description – Senior IT Product Analyst

Domain: Pharmaceutical R&D / Preclinical / Laboratory Informatics

We are seeking a Senior IT Product Analyst to support digital solutions within Assay Data Processing and Electronic Notebook (eNotebook) environments for pharmaceutical R&D. This role acts as a bridge between scientific stakeholders, business teams, and IT
, ensuring that GxP-compliant laboratory systems meet both regulatory standards and evolving scientific needs. The ideal candidate combines strong clinical/lab domain expertise with product analysis and system implementation experience
, particularly in LIMS, eNotebook platforms, and clinical trial-related systems
.

Product & Business Analysis

• Collaborate with Product Owner and Product Management to define and evolve product roadmap for assay data processing and eNotebook capabilities
• Elicit, analyze, and document business and functional requirements across scientific, clinical, and IT stakeholders
• Lead discovery sessions, workflow analysis, and requirement workshops with laboratory and R&D teams
• Translate complex lab workflows into system configurations, user stories, and functional specifications

System Implementation & Lifecycle Management

• Support implementation, configuration, and lifecycle management of:
• eNotebook solutions (e.g., Revvity Signals or similar)
• LIMS platforms and assay data management systems

• Ensure compliance with GxP, GMP, GCLP, CLIA, FDA, and 21 CFR Part 11 (e-signatures, data integrity)
• Support validation activities including documentation, audit readiness, and traceability
• Partner with QA and Regulatory teams on change control, validation strategy, and compliance checks

• Lead and support UAT (User Acceptance Testing) and validation testing cycles
• Coordinate onboarding, training, and documentation for new features and releases
• Monitor user feedback and drive adoption improvements

• Act as SME between:
  • Laboratory scientists / clinical users
  • IT engineering teams
  • QA / regulatory stakeholders
• Support cross-functional delivery in a product-driven environment

Experience

• ~10–15+ years of experience in:
• Laboratory informatics / clinical R&D IT
• Product analysis / business analysis in regulated environments

• Deep understanding of:
• Clinical R&D lab processes (preclinical / assay data / biobanking)
• Laboratory workflows, sample tracking, and TAT processes
• Familiarity with systems such as:
• LIMS (Lab Vantage, STARLIMS, Lab Daq, Epic Beaker, etc.)
• RTSM (e.g., Synapse, CP4)
• EDC (e.g., Medidata Rave)
• EMR/EHR systems (Epic, Cerner)

• Strong knowledge of:
• GxP (GMP, GCLP)
• ICH guidelines
• CLIA, FDA regulations
• Data integrity, validation, and audit processes

• Requirements management tools (JIRA, Confluence)
• Process modeling and documentation (Visio, Lucidchart)
• SQL (working knowledge)
• CRM/Integration exposure (Salesforce, billing systems such as Xifin – nice to have)
• Collaboration tools (MS Teams, SharePoint, etc.)

• Background as Medical Laboratory Scientist / Scientific Analyst
• Experience in pre-sales / solution consulting for LIMS or lab digital platforms
• Hands-on experience in system configuration, demo setup, and client-facing workshops
• Ability to bridge scientific depth + product mindset + client engagement
• Exposure to biobanking, genetic testing systems, or assay data pipelines

• Bachelor’s or Master’s degree in:
  • Life Sciences, Clinical Laboratory Science, or related field
  • (Advanced degree preferred)

• Operates as true SME, not just BA — understands lab science and can challenge requirements
• Comfortable in client-facing workshops, demos, and solution positioning
• Able to translate lab workflows into system configurations (not just documentation)
• Strong credibility with both:
• Scientists (domain depth)
• IT/delivery teams (system & product understanding)
• Experience contributing to complex, high-value digital lab solutions and implementations