Katalyst Healthcares and Life Sciences
Business Analyst (Clinical Trial)
Katalyst Healthcares and Life Sciences, Princeton, New Jersey, us, 08543
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. 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.