Business Analyst Clinical Trial
Business Analyst Clinical Trial
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Salary Not Disclosed
1 Vacancy
Job Description
- Lead requirement gathering sessions with crossfunctional stakeholders.
- Identify business needs and translate them into analytics and reporting requirements.
- Author GxP and nonGxP 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 realword 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.
- Bachelors 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 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.
Employment Type
Full Time
