Bachelor's degree or equivalent in a science discipline or related field
7-10 years of pharmaceutical industry or related experience in implementing Clinical solutions
Knowledge of clinical data management activities and processes
Experience with clinical operations and PV
Requirements:
Responsible for planning, business requirement/user story development for reports/visualization needs
Author and refine system support processes, flow diagrams, configurations, and interdependencies
Partner with Testing team to draft and review UAT scripts and manage end to end UAT process
Ensure compliance with regulatory requirements/controls related to business systems and IT infrastructure
Job description
Job Title: Senior Business Analyst - GxP, Pharmaceuticals
Duration: 6 months plus
Location: 100% remote
• The Senior Business Analyst is responsible for planning, business requirement/user story development for reports/visualization needs in support of our DevTech Products
• Author and refine system support processes, flow diagrams, configurations, and interdependencies
• Experience with clinical operations and PV
• Partner with Testing team to draft and review UAT (User Acceptance Testing) scripts and manage end to end UAT process until product release closure.
• Effectively translates business requirements into user stories and supporting documents like detailed requirement specifications for the agile development team
• Ensure compliance with regulatory requirements/controls related to business systems and IT infrastructure
• Highlight potential risks and act proactively to resolve issues
• Follow company and departmental policies, procedures and ensure documentation according to the Quality Management Systems (QMS), Software Development Life Cycle, and Project Life Cycle standards.
• Work independently with stakeholders to prioritize requirements and is a primary resource on complex issues within a clear framework of accountability.
• Establish relationships with colleagues across Takeda and analyze issues and guide the development of solutions within ongoing processes.
• Build and maintain relationships with key business stakeholders
Functional Requirements:
• Bachelor's degree or equivalent in a science discipline or related field
• 7-10 years of pharmaceutical industry or related experience in implementing Clinical solutions
• Knowledge of clinical data management activities and processes, data review and visualization tools
