Business Analyst with Clinical Trails

About

Momento USA is a global technology consulting, talent acquisition, and creative development firm that addresses clients' most pressing needs and challenges.

Position

Business Analyst with Clinical Trails

Location

Remote

Employment Type

Contract

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 Clinical Ink's eSource ecosystem.

Roles & 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 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 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.