- 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.
- 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.
- Ability to operate effectively in a GxP matrix environment; team player yet able to work independently with minimal direction.
- 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.
- Excellent oral and written communication skills; able to organize and clearly present ideas in a convincing and compelling manner.
- 5+ years' experience as a Sr. Business Analyst, with working command of requirements engineering, analysis tools and techniques.
- Highly experienced in SDLC management and iterative systems development methodologies with emphasis with eTMF system management.
- 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
- Familiarity with GxP, CFR 21 Part 11 and systems validation.
- Knowledge:
- Regulatory audit and inspection support
- Tools and Technology awareness: 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.
- Advanced degree
- CBAP
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Senior Business Analyst - Cambridge, United States - Biogen Idec
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:
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:
Who You Are
Why Biogen?
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. Together, we pioneer. Together, we thrive.
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. Read on to learn more about our DE&I efforts.
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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