Responsibilities:

• Lead requirement gathering sessions with cross-functional stakeholders.
• Identify business needs and translate them into analytics and reporting requirements.
• Author GxP and non-GxP documentation, including URS, FRS, design specs, system support plans, and business continuity plans etc.
• Conduct stakeholder demos, review meetings, and gather feedback to refine analytics approach and outcomes.
• Facilitate UAT sessions with end users to validate dashboard functionality.
• Explain requirements to the development and testing teams to ensure proper implementation.
• Collaborate with Business Intelligence and Database development teams to support analytics development, resolve issues, and ensure seamless integration.
• Collaborate with vendors on data acquisition and integration strategies.
• Analyze real-word data sources and data in our relational database repository to aid in the definition of analytic requirements and development of KPIs.
• Provide Business Intelligence platform training to new stakeholders across the organization.
• Support project management activities, including defining timelines, tracking deliverables, identifying risks, and ensuring alignment with timelines.

Requirements:

• Bachelor’s degree in Statistics, Mathematics, Computer Science, Life Sciences or a related field.
• Minimum 7+ years of Business Analyst experience is required.
• Clinical Trial domain expertise, including Study Execution, Site Monitoring, Data Management, and Patient Safety.
• Exposure to Pharmacovigilance, and Quality and Compliance processes preferred.
• Experience with SQL and relational databases for data analysis.
• CSV & GxP documentation knowledge (URS, FRS, validation, audit trails).
• Familiarity with clinical systems (EDC, eSource, CTMS, eTMF, Regulatory Compliance).
• Strong communication and stakeholder management skills to lead requirement discussions, demos, and collaboration efforts.
• Project coordination experience, including timeline management and risk identification.
• Ability to work independently and as part of a team.
• Experience in principles of Change Management.

• Lead requirement gathering sessions with cross-functional stakeholders.
• Identify business needs and translate them into analytics and reporting requirements.
• Author GxP and non-GxP documentation, including URS, FRS, design specs, system support plans, and business continuity plans etc.
• Conduct stakeholder demos, review meetings, and gather feedback to refine analytics approach and outcomes.
• Facilitate UAT sessions with end users to validate dashboard functionality.
• Explain requirements to the development and testing teams to ensure proper implementation.
• Collaborate with Business Intelligence and Database development teams to support analytics development, resolve issues, and ensure seamless integration.
• Collaborate with vendors on data acquisition and integration strategies.
• Analyze real-word data sources and data in our relational database repository to aid in the definition of analytic requirements and development of KPIs.
• Provide Business Intelligence platform training to new stakeholders across the organization.
• Support project management activities, including defining timelines, tracking deliverables, identifying risks, and ensuring alignment with timelines