LIMS/Validation Business Analyst

Business AnalystWe need 2-3 Business Analysts who are local to MA and can come on site 2 times a week/8 times in a month. Need someone with Validation experience- LIMS, LabVantage, LabWare Someone who has involved in LIMS or LabVantage implementation would be ideal Agile experience (nice to have) Lab system experience Pharma expThe Business Analyst will support the requirement gathering and implementation of Clinical Laboratory Digital software and systems. Fundamentally you are a business analyst who enjoys interacting with your end users and can drive product definition and execution in a fast-moving digital organization. You understand and practice agile end user centered design methodology. You are passionate about drug development and bringing new medicines to patients.Here’s What You’ll Do:Elicit end user design workshops for the collection and refinement of personas, epics and user stories. Validate and document business and functional requirements for system features and/or process changes.Author/co-author documents: epics, user stories and associated functional and design documents, Configuration Specifications, Test Plans, Work Instructions, SOPs, etc.Assist with creation of test plans and detailed test cases to validate that functional requirements are met. When appropriate, lead user acceptance testing (UAT) efforts to ensure the software implementation meets the needs of business end users.Lead teams of users through support meetings, reviewing key points of concerns and escalating where necessary. Build strong and positive working relationships with all functional areas across the company and understand their needs.Help business stakeholders envision the future and how their work will need to change to support the future. Work in partnership with stakeholders to improve the business processes impacted by technology changes.Approach problem solving and system design from end-user experience perspective, using user-centered design principles and encouraging intuitive and streamlined UIs/workflows when possible.Support product owners in product backlog grooming and release definition. Post-implementation, evaluate progress made against the business objectives for the project to show the extent to which they were fulfilled. Suggest follow-up projects and initiatives as needed to fully realize the intended objectives.Assist with systems integration design to deliver maximum efficiency and business value, while considering information flow and data requirements.Analyze and develop interim and future-state business system process documentation that articulates exactly what changes are required.Assist in the authoring and execution of validation artifacts for user acceptance testing and operational qualification testing.Assist in the authoring of procedural documents (SOPs)Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.Train end users to ensure they understand all processes and procedural changes. Collaborate with training staff to create appropriate training materials and deliver the training.Collaborate with business stakeholders across clinical operations, bio-sample management and regulatory business units to understand their current and future state goals and objectives from a global perspective in a high growth fast-paced environmentHere’s What You’ll Bring to the Table:At least 5 years’ experience in the definition, design, implementation and support of solutions in one or multiple clinical and medical systems: LIMS, SDMS, laboratory instrument and analytical software, and sample management systemsProven experience with external vendor integration (CRO, central labs, imaging labs etc.), and vendor technology managementExperience with Computerized System Validation and global regulatory requirements for data privacy and protection (GDPR)Tangible record of accomplishment in using Agile approaches for product developmentDemonstrable experience in Design Thinking.Working knowledge of cloud-based requirement management and agile process management tools (Jira, Confluence, Asana or similar)Fluent in the digital world. You have first-hand knowledge of technology in a GxP environment and practical understanding of data integrity requirements for systems used in the conduct of clinical trials.Working knowledge of clinical, manufacturing or research operations, clinical data management, regulatory processes in a drug development contextYou work independently yet engage proactively with team members, colleagues and stakeholders to get alignment and drive projects forward.You do not hesitate to dive in and work alongside the team. You can effectively manage conflicting priorities in a fast-paced environment, and you can navigate ambiguity effectively.You put team before tasks by collaborating actively with all team members and supporting them.A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and CollaborativeBachelor's degree in Computer Science, Biotechnology, Life Science or equivalent required. Master's preferred. Samprasoft