Role : Business Analyst (BA Clinical/Pharma)
Location- Remote
Duration : 12 Months
Job Description
- The Business Analyst (BA) will serve as a key liaison between clients, product teams, clinical operations, and technical delivery teams.
- The BA will gather, analyze, and translate complex clinical trial requirements into functional specifications for eSource, DDC, and eCOA solutions.
- This role requires strong understanding of clinical trial processes, data capture workflows, regulatory expectations (GCP, FDA 21 CFR Part 11), and technology used in decentralized clinical trials.
- The BA ensures successful planning, configuration, validation, and delivery of high‑quality study builds within Client’s eSource ecosystem.
Roles and Responsibilities:
- Requirements Gathering & Analysis Engage with sponsors, CROs, and internal stakeholders to understand protocol‑level requirements.
- Analyze study protocols to extract data points, visit schedules, forms, workflow dependencies, and assessment requirements.
- Translate clinical and operational needs into clear functional & technical specifications for: DDC forms / eSource modules eCOA instruments (screen/ePRO/eClinRO) Device integrations and data ingestion
- Workflow automation and monitoring dashboards
- Conduct gap analyses, feasibility assessments, and risk identification for DCT implementations.
- Study Design & Solution Configuration Collaborate with product configuration teams to design data collection forms and logic.
- Define requirements for edit checks, branching logic, visit windows, and data validation rules. Support build activities for eSource, DDC, eCOA, and hybrid trial setups.
- Create study maps, CRF specifications, data dictionaries, and workflow diagrams. Ensure designs align with Client’s platform capabilities and regulatory requirements.
- Client & Stakeholder Interaction Act as primary business liaison during study initiation and implementation.
- Conduct workshops with clinical, data management, and medical teams to validate requirements.
- Provide strategic consultation on DCT readiness, eSource adoption, and data capture optimization.
- Present requirement documents, UAT plans, and system design walkthroughs.
- Documentation & Quality Control Produce high‑quality business requirement documents (BRDs), functional specifications (FS), and user stories.
- Maintain traceability matrices to track requirement coverage.
- Support validation documentation including: User Acceptance Testing (UAT) cases Functional test validation Regulatory compliance evidence Ensure documentation meets GxP, 21 CFR Part 11, and audit-ready standards.
- Cross‑Functional Collaboration Partner with: Product Managers Clinical Operations Data Management Engineering Project/Program Managers QA/Validation teams Participate in Agile ceremonies (sprint planning, grooming, demos).
- Support troubleshooting and triage during study conduct.
- Continuous Improvement Provide insights on platform enhancements based on client feedback.
- Contribute to reusable templates, best practices, and process improvements for DCT and eSource study builds.
- Stay updated on clinical data standards (CDISC, SDTM), industry trends, and regulatory changes.