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Senior Business Analyst - R&D IT

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Biogen

2024-04-25 06:38:15

Job location Cambridge, Massachusetts, United States

Job type: fulltime

Job industry: Consulting & Corporate Strategy

Job description

Job Description

About This Role

The R&D IT Senior Business Analyst (BA) will play an active role in supporting GXP applications in the Clinical Sciences business area, specifically the electronic Trial Master File (eTMF). The BA has responsibility for the health and success of eTMF and related projects within a matrixed organization with direct relationships with various groups in the business as well as IT.

This role requires the ability to:

Monitor, manage, and ensure predictable delivery of eTMF projects in a deadline-driven, regulated environment. Act as Project Manager for small projects.

Drive delivery and accountability of internal staff as well as vendors and third-party project managers. Own the quality of the project deliverables.

Enable early identification and escalation of risks and issues that require assistance, attention, or executive resolution.

Own the eTMF system lifecycle management process and compliance requirements.

Effectively communicate system and project status to leadership; verbal or written.

What You'll Do

The BA is responsible for ensuring that system compliance and project deliverables are of high quality and meets GxP compliance standards. The BA works with project teams to deliver with high quality and timely cadence. The BA will facilitate activities of Biogen-internal resources, external vendors and other partners.

The key activities for this position include:

Develop GxP-compliant SDLC deliverables.

Document business processes and use cases.

Translate business to technical requirements. Drive understanding of deliverables.

Provide appropriate technical/functional software support throughout product and project lifecycles.

Assist testing staff in designing test plans and test scripts to validate functional requirements.

Co-author operational support documentation.

Support deployment and hypercare activities.

Complete other ad hoc tasks, as requested.

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