Business Analyst (Pharma Clinical Trial Experience)

Job Title: Business Analyst (Pharma Clinical Trial Experience is must)

Role Type: Contract, Hybrid

Location: Princeton, NJ

Contract Length: 12 Months

How to Apply: Please send your resume and contact information to recruiters at 4aitservices dot com

This is a hybrid position and candidate is required to come onsite in Princeton, NJ.

This is a long term position.

The duties include:

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.

Required Skills and Qualifications:

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

Good-to-Have Qualifications:

Experience in principles of Change Management.