IT Business Analyst Project Manager
IT Business Analyst Project Manager
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1 Vacancy
Job Description
Job Title: IT GxP Business Analyst & Project Manager
Location: Remote (Must be available during U.S. Eastern business hours)
Salary Range: $3500 $5500 USD/month
Position Overview
We are seeking an experienced IT GxP Business Analyst & Project Manager to lead the alignment of evolving enterprise technologies with critical business strategies. This role is pivotal in translating complex Clinical Regulatory and Quality business needs into actionable systems and design specifications. It requires both strategic vision and hands-on project with a strong emphasis on regulatory compliance process improvement and cross-functional collaboration.
Key Responsibilities
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Lead the design and implementation of IT projects following SDLC methodologies.
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Facilitate requirements-gathering sessions across Clinical Regulatory Quality and IT teams.
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Analyze and improve business systems and workflows; identify compliance risks and process inefficiencies.
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Translate business requirements into system specifications guiding software development testing and validation activities.
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Implement governance processes ensuring GxP GDPR HIPAA and SOX compliance.
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Manage the full lifecycle of GxP-regulated projects: develop timelines track deliverables and ensure on-time .
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Provide clear consistent communication and reporting across cross-functional stakeholders.
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Monitor and address project risks proactively managing issues to maintain momentum.
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Promote a collaborative accountable team culture.
Qualifications
Education:
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Bachelor s degree in a science-related or technical field.
Experience:
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Strong background in GxP Biopharma Business Analysis & Project Management.
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Experience gathering and documenting requirements for practical implementation.
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Proficiency in ITIL-based service management and software development oversight.
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Familiarity with methodologies such as GAMP5 Agile and Waterfall.
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Experience with Clinical systems (CTMS EDC eTMF SCE) preferred.
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Experience with Quality systems (QMS QDocs) preferred.
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Availability to work aligned with U.S. Eastern Time Zone.
Certifications (preferred but not required):
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PMP ITIL or PRINCE2
Employment Type
Full Time
