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    Senior business analyst it - Cambridge, Cambridgeshire, United Kingdom - Reporter Newspapers

    Reporter Newspapers
    Reporter Newspapers Cambridge, Cambridgeshire, United Kingdom

    1 week ago

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    Description

    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.

    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; 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. Document business processes and use cases.
    Translate business to technical requirements. 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.
    Support deployment and hypercare activities.
    Complete other ad hoc tasks, as requested.

    Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and SaaS vendors.

    Business Analyst, with working command of requirements engineering, analysis tools and techniques.
    ~ BA or BS in Computer Sciences or Data Sciences required.
    ~ IT System Owner (Product Manager) - change and release management, validation planning and execution, and system lifecycle management
    ~ Regulatory audit and inspection support
    ~ IQVIA eTMF, Veeva eTMF, CAPA/Deviation management, system management reviews, ServiceNow, ALM VERA, Document Management system, MS Project, MS Visio and standard MS Office products.


    Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team.

    We work together to overcome obstacles and to follow the science.

    We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine.

    At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve.

    We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.

    All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.

    Biogen is an E-Verify Employer in the United States.
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