Business Analyst

Skills

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) as needed to confirm that software implementations meet business needs. Lead 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 whenever possible. 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.

Description

We are looking for a skilled Business Analyst to support the requirement gathering and implementation of our Clinical Laboratory Information Management Systems (LIMS). This role involves running workshops, collecting timely information from business stakeholders, and working closely with teams to understand their roles and processes. An in-depth background in LabVantage LIMS and experience with software deployment in a GxP environment are essential. Familiarity with FDA standards and regulatory processes in Clinical Labs is a significant advantage.

Responsibilities

• At least 5 years of experience in the design, implementation, and support of LabVantage 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.
• Bachelor’s degree in computer science, Biotechnology, Life Sciences, or an equivalent field is required.