Intellectt Inc

Clinical Business Analyst - LIMS Lab Vantage

Intellectt Inc Norwood, MA

Job Title: Clinical Lab Vantage LIMS - Business Analyst

Location: Norwood, MA

Onsite / Remote: Onsite (3-4 times a week)

Visa Requirements: Any Visa

Overview: We are seeking a skilled Business Analyst to support the requirement gathering and implementation of our Clinical Laboratory Information Management Systems (LIMS). The ideal candidate will have an in-depth background in LabVantage LIMS, experience with software deployment in a GxP environment, and familiarity with FDA standards and regulatory processes in Clinical Labs.

Responsibilities

  • Document business and functional requirements for system features and process changes.
  • Lead end-user design workshops to refine personas, epics, and user stories.
  • Author or co-author essential documents, including epics, user stories, functional and design documents, Configuration Specifications, Test Plans, Work Instructions, and SOPs.
  • Assist in creating test plans and detailed test cases to ensure functional requirements are met.
  • Lead user acceptance testing (UAT) to confirm that software implementations meet business needs.
  • Conduct support meetings with users, review key concerns, and escalate issues as necessary.
  • Build strong relationships with all functional areas and understand their needs.
  • Help stakeholders envision future changes and work in partnership to improve business processes affected by technology changes.
  • Approach problem-solving and system design from the end-user experience perspective, using user-centered design principles and encouraging intuitive and streamlined UIs/workflows.
  • Support product owners in product backlog grooming and release definition.
  • Evaluate progress against business objectives post-implementation and suggest follow-up projects as needed.
  • Assist with systems integration design to deliver maximum efficiency and business value while considering information flow and data requirements.
  • Analyze and develop business system process documentation, clearly articulating required changes.
  • Train end-users on new processes and procedural changes and collaborate with training staff to create and deliver training materials.
  • Collaborate with stakeholders across clinical operations, bio-sample management, and regulatory business units to understand their global goals and objectives in a high-growth, fast-paced environment.

Qualifications

  • Bachelor’s degree in Computer Science, Biotechnology, Life Sciences, or a related field.
  • At least 5 years of experience in the design, implementation, and support of Lab Vantage LIMS.
  • Knowledge of SDMS, laboratory instruments, analytical software, and sample management processes is a plus.
  • First-hand knowledge of technology in a GxP environment and an understanding of data integrity requirements for clinical trials.
  • Working knowledge of clinical, manufacturing, or research operations, clinical data management, and regulatory processes in drug development.
  • Proficiency in cloud-based requirement management and agile process management tools (e.g., Jira, Confluence).
  • Ability to work independently while engaging proactively with team members and stakeholders.
  • Effective management of conflicting priorities and navigating ambiguity in a fast-paced environment.
  • Desire to be part of a high-growth, transformational company that is bold, relentless, curious, and collaborative.
  • Seniority level

    Associate
  • Employment type

    Contract
  • Job function

    Research, Analyst, and Information Technology
  • Industries

    Pharmaceutical Manufacturing

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