Senior IT Product Analyst (pharma, medical)

Link Group is hiring for a Senior IT Product Analyst role focused on pharmaceutical R&D digital solutions, particularly in Assay Data Processing and Electronic Notebook (eNotebook) environments. The position involves working within highly regulated clinical laboratory and R&D IT domains.

• Approximately 10–15+ years of experience in laboratory informatics, clinical R&D IT, or product/business analysis within highly regulated environments.
• Strong background in clinical laboratory operations, assays, or diagnostic testing workflows.
• Proven track record in implementing or supporting LIMS and/or eNotebook platforms.
• Experience supporting clinical trial systems (e.g., RTSM, EDC) is a strong advantage.
• Deep understanding of clinical R&D lab processes including preclinical workflows, assay data pipelines, biobanking, sample tracking, and TAT processes.
• Familiarity with LIMS (LabVantage, STARLIMS, LabDaq, Epic Beaker), RTSM, EDC (Medidata Rave), or EMR/EHR systems (Epic, Cerner).
• Robust knowledge of GxP (GMP, GCLP), ICH guidelines, FDA/CLIA regulations, data integrity standards, and audit processes.
• Proficiency in requirements management tools (JIRA, Confluence).
• Expertise in process modeling and documentation software (Visio, Lucidchart).
• Working knowledge of SQL.
• Nice to have: Exposure to CRM/Integration tools (Salesforce) or specialized billing systems (Xifin).
• Bachelor’s or Master’s degree in Life Sciences, Clinical Laboratory Science, or related technical/scientific field; advanced degree preferred.

• Collaborate with Product Owners and Product Management to define and evolve the product roadmap for assay data processing and eNotebook capabilities.
• Elicit, analyze, and document requirements across scientific, clinical, and IT stakeholders.
• Lead discovery sessions, workflow analysis, and requirement workshops with lab teams.
• Support implementation, configuration, and lifecycle management of eNotebook solutions and LIMS platforms.
• Configure and run system demos to reflect client workflows.
• Ensure compliance with GxP, GMP, GCLP, CLIA, FDA, and 21 CFR Part 11 guidelines.
• Support validation activities including documentation, audit readiness, and traceability tracking.
• Lead and support User Acceptance Testing (UAT) and validation testing cycles.
• Coordinate onboarding, user training, and product documentation for new features and releases.
• Act as the core Subject Matter Expert (SME) aligning laboratory scientists, IT engineering teams, and QA/regulatory stakeholders.