Business Analyst

Role: Business Analyst (Clinical / Pharma Domain) 

Location: Cambridge, MA 02142 (100% Onsite)

Key Responsibilities

·         Gather, analyze, and document business and functional requirements.

·         Facilitate stakeholder discussions, workshops, and requirements-gathering sessions.

·         Create user stories, process flows, acceptance criteria, and business documentation.

·         Collaborate with cross-functional teams to optimize clinical data review workflows.

·         Support Agile ceremonies, backlog management, end-user demos, UAT, and solution validation.

·         Analyze data and reporting requirements to support informed business decisions.

·         Ensure solutions align with regulatory, quality, and operational standards.

·         Required skills:

·         Bachelor’s degree or equivalent in a science discipline or related field.

·         7–10 years of Analyst Business experience implementing clinical solutions.

·         Familiarity with clinical data management activities and processes, including data review and visualization tools.

·         Knowledge of EDC platforms such as Veeva EDC, elluminate, or similar systems.

·         Proficient knowledge of Quality Assurance/Compliance processes, 21 CFR Part 11, and other GxP regulations.

·         Proficient in working within an SDLC framework, including Delivery, Testing, Software Quality Assurance, and Change Management.

·         Hands-on experience with Agile tools such as the Atlassian Suite (JIRA/Confluence) and leveraging agents to create/manage user stories and risk profiling.

·         Ability to articulate complex technical problems and solutions to a broad business audience and communicate solution value.

·         Excellent written and verbal communication and presentation skills.

·         Ability to identify operational weaknesses and implement corrective action plans.

·         Experience working remotely with global teams.