Business Analyst, Clinical Laboratory Systems

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Job description

RESPONSIBILITIES:

Kforce has a client that is seeking a Business Analyst, Clinical Laboratory Systems in Cambridge, MA. The Role: This role is an exciting opportunity to be a critical part of the company's growing Clinical and Medical Digital Systems Team, supporting a high-growth organization that is radically changing the biotech industry. Reporting to the Director, BioMarkers and Clinical Laboratory Systems, the Business Analyst will support the requirement gathering and implementation of Clinical Laboratory Digital 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 lean and user centered design methodology. You are passionate about drug development and bringing new medicines to patients. Key Tasks:

• Business Analyst will lead user centered design workshops for the collection and refinement of personas, epics, and user stories
• Author requirement documents: epics, user stories and associated functional and design documents
• Support product owners in product backlog grooming and release definition
• 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 environment
• As a Business Analyst, you will assist in the authoring of validation artifacts for user acceptance testing and procedural documents (SOPs)

Job Requirements:

REQUIREMENTS:

• Bachelor's degree in Computer Science, Biotechnology, Life Science or equivalent required; Master's preferred

At least 5 years of experience in the definition, design, implementation, and support of solutions in one or multiple clinical and medical systems:

• LIMS
• SDMS
• Analytics Platforms (Spotfire, Tableau, etc.)
• SDMS Solutions
• Laboratory Instrument Control Software
• Sample Management
• You have proven experience with external vendor integration (CRO, central labs, imaging labs etc.), and vendor technology management
• Experience with Computerized System Validation and global regulatory requirements for data privacy and protection (GDPR)
• Tangible record of accomplishment in using Agile approaches for product development
• Demonstrable experience in Design Thinking
• Working knowledge of cloud-based requirement management and agile process management tools (Jira, Confluence, Asana or similar)
• As a technologist, you know your craft and you are fluent in the digital world
• You have a working knowledge of clinical, manufacturing or research operations, clinical data management, regulatory processes in a drug development context
• You 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 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 Collaborative

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.