Clinical Research IT Business Analyst (VISA INDEPENDENT CANDIDATES ONLY)

Regulated environments such as CRO organizations experience is Huge plus

Job Purpose:

The Senior Business Analyst (SBA) partners closely with business and technical stakeholders to uncover the true needs of the organization and translate them into clear, actionable, and testable requirements. This role ensures solutions are designed with the end user in mind while meeting enterprise, quality, and regulatory expectations.

Key Accountabilities:

Elicit and define business requirements

• Identify true business needs using a consulting mindset, distinguishing between need and want.
• Gather, analyze, and refine business and functional requirements through stakeholder interviews, workshops, and documentation reviews.
• Produce clear, complete, and unambiguous requirements documentation, including functional requirements, user stories, process flows, and acceptance criteria.

Maintain traceability and support test coverage

• Own and maintain requirements traceability matrices (RTMs) to ensure all requirements are fully tested.
• Partner with QA, Technology Quality Management, and delivery teams to validate requirements, acceptance criteria, and test scenarios.
• Support the definition of User Acceptance Test (UAT) criteria and scenarios and participate in UAT preparation, dry runs, and execution as needed.

Facilitate workshops and stakeholder alignment

• Facilitate and co-chair workshops, interviews, and working sessions with cross-functional SMEs and stakeholders.
• Drive collaborative agreement, prioritization, and decision-making across business and technology teams.
• Communicate effectively with senior stakeholders, sponsors, and functional leaders to align on scope and outcomes.

Translate business needs to technology delivery

• Act as the primary translator between business stakeholders and engineering teams, ensuring shared understanding of requirements and solution intent.
• Serve as the voice of the customer within Scrum or delivery teams when a business SME is not embedded.
• Assist in identifying technical capabilities and solution approaches that align with desired business outcomes.
• Partner with UX and Human Factors Engineering (HFE) specialists to ensure requirements support intuitive, user-centered solution design.

Enable continuous improvement

• Apply Business Analysis best practices to continuously improve processes, standards, templates, and ways of working.
• Identify opportunities to streamline workflows and improve efficiency while maintaining quality and compliance.
• Contribute to the maturity of Business Analysis practices across initiatives and programs.

Skills:

Required Skills

• Strong consulting skills, including root cause analysis and the ability to distinguish between true needs and stated wants.
• Excellent verbal and written communication skills, with the ability to translate complex discussions into structured documentation.
• Proven ability to negotiate, influence, and build consensus with senior stakeholders.
• Strong requirements documentation and analytical skills.
• Ability to learn new domains quickly and share knowledge effectively across teams.
• Ability to work effectively in fast-paced, cross-functional, and globally distributed environments.
• Comfortable balancing multiple initiatives and priorities simultaneously.

Experience with Generative AI (Preferred)

• Requirements drafting and refinement: Using tools such as Copilot to draft user stories, acceptance criteria, or process documentation from meeting notes, then refining for accuracy and compliance.
• Process analysis and optimization: Leveraging AI to analyze workflow descriptions, identify gaps, and propose streamlined future-state processes.
• Workshop acceleration: Preparing workshop materials (e.g., scenarios, draft journeys) and rapidly synthesizing outputs into structured requirements and traceability artifacts.
• Data interpretation and summarization: Summarizing large documents, logs, or research materials to accelerate impact analysis and understanding.
• Test case support: Generating first-draft test scenarios from user stories and acceptance criteria, then validating with QA.
• Backlog grooming assistance: Supporting story decomposition, clarifying ambiguity, and identifying duplication or conflicts across large backlogs.

Knowledge and Experience:

• Strong understanding of clinical trials and variations across Phases I IV.
• Solid grounding in Business Analysis best practices and consulting behaviors.
• Familiarity with Computer System Validation (CSV), SDLC methodologies, and 21 CFR Part 11 concepts.
• Experience working within regulated environments such as pharmaceutical, biotech, or CRO organizations.
• Experience supporting project delivery within established Project Lifecycle (PLC) frameworks.