Requirement details:
Role: Business Analyst with Clinical Trails
Location: Remote
Duration: 12+ Months
Job Description:
10+ Years of Experience
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 (Google Cloud Platform, FDA 21 CFR Part 11), and technology used in decentralized clinical trials.
The BA ensures successful planning, configuration, validation, and delivery of highquality study builds within Clinical Ink s eSource ecosystem.
Roles & Responsibilities:
- Requirements Gathering & Analysis Engage with sponsors, CROs, and internal stakeholders to understand protocollevel 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 Clinical Ink 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 highquality 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.
- CrossFunctional 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.
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