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Business Analyst, Clinical Laboratory Systems


Location: Cambridge, Massachusetts
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Description:
The Role:

This role is an exciting opportunity to be a critical part of Moderna’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.

Here’s What You’ll Do:

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.

Assist in the authoring of validation artifacts for user acceptance testing and procedural documents (SOPs)

Here’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

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 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.

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 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 Collaborative

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