Business Analyst

Job Title: Business Analyst Location: Remote Job Type: Contract Job Description: key responsibilities: • Meet with stakeholders to gather and evaluate remaining requirements • Analyzing and translating business needs into BRDs, user stories, and acceptance criteria, • Experience with CTMS, eTMF, RBQM, and EDC, leading to the successful implementation of clinical systems and processes • Document requirements and ensure requirements are approved by BPO and filed in GVault • Partner with Developer to ensure they have information needed to implement dashboard • Partner with Developer to demo dashboard for stakeholders every 2-3 weeks to confirm requirements/solution • Partner with SQA tester to ensure they have the information needed to complete SQA testing • Author UAT test plan/summary report and coordinate end user testing of the dashboard Secondary • Experience working as a Business Analyst at biotech/pharma companies- Nice to have • Familiarity with Spotfire or Power BI capabilities - Nice to have Job Description of Role • (RNR) - We are seeking a Business Analyst with requirement gathering, documentation, and stakeholder engagement within the clinical domain. The ideal candidate will have strong expertise in analyzing and translating business needs into BRDs, user stories, and acceptance criteria, while collaborating closely with development, QA/UAT, and project management teams to ensure successful delivery. Hands-on experience with clinical systems such as CTMS, eTMF, RBQM, and EDC is highly preferred. The role requires excellent communication and problem-solving skills, along with proven ability to work with business teams to refine requirements and ensure alignment with project goals and deliverables. Soft skills/other skills - Communication Skills: Communicate effectively with internal and customer stakeholders (technical and non-technical ) Communication approach: verbal, emails and instant messages Interpersonal Skills: Strong interpersonal skills to build and maintain productive relationships with team members Provide constructive feedback during reviews and be open to receiving the feedback. Problem-Solving and Analytical Thinking: Capability to troubleshoot and resolve issues efficiently. Analytical mindset Task/ Work Updates Prior experience in working on Agile/Scrum projects with exposure to tools like Jira/Azure DevOps Provides regular updates, proactive and due diligent to carry out responsibilities Expected Outcome The Business Analyst will ensure that business requirements are clearly understood, documented, and translated into actionable deliverables, leading to the successful implementation of clinical systems and processes. The role is expected to drive alignment between stakeholders, technical teams, and project managers, ensuring that all solutions meet business objectives, comply with industry standards, and are delivered on time with high quality. Secondary Skills to be planned Post Hiring - Training Plan In addition to core business analysis expertise, the candidate should bring secondary skills such as knowledge of regulatory guidelines (e.g., 21 CFR Part 11 and GxP compliance), familiarity with Agile/Scrum methodologies and tools like Jira, Azure DevOps, or HP ALM, and strong SQL and data analysis capabilities to support requirement validation and testing. Proficiency in MS Office tools (Excel, PowerPoint, Visio, Project) for documentation and presentations, along with experience in preparing training materials, user guides, and process documentation, will be valuable. The ability to facilitate workshops, requirement sessions, and stakeholder discussions is also expected. Primary (Must have skills) • - • 5+ years of experience analyzing requirements, documenting findings, and ensuring effective communication and clarification with stakeholders. • 3+ years of proven expertise in the clinical domain and operations, including hands-on experience with systems like CTMS, eTMF, RBQM, and EDC. • 5+ years of experience in creating detailed BRDs, user stories, and acceptance criteria, and collaborating with technical teams to define specifications and designs. • 4+ years of experience coordinating with development and QA/UAT teams, supporting test planning, reviews, and ensuring deliverables meet business requirements. • 3+ years of experience working with project managers and business teams to align scope, refine requirements, and support successful project delivery.