Business Analyst - WFH
About the Company
The hiring company is seeking a Business Analyst to support clinical trial technology initiatives within the pharmaceutical and clinical research domain.
About the Role
The Business Analyst – Clinical Trials will support clinical trial technology by translating study protocols and clinical requirements into functional specifications, data collection workflows, and system configurations. This role requires strong experience in Pharma, Clinical Research, or Clinical Trials, along with hands-on business analysis experience with clinical technology solutions. You will work with sponsors, Contract Research Organizations (CROs), Clinical Operations, Data Management, Quality Assurance, and technical teams to define study requirements, support study builds, and ensure clinical workflows meet applicable regulatory and validation requirements.
Key Responsibilities
Analyze clinical study protocols and translate them into clear business and functional requirements. Define study requirements, clinical workflows, visit schedules, data collection forms, edit checks, and validation rules. Support study builds and data capture workflows for clinical trial technology solutions. Work with eSource, DDC, eCOA, ePRO, or other eClinical solutions to support clinical study requirements. Prepare Business Requirements Documents (BRDs), functional specifications, user stories, workflow diagrams, and traceability matrices. Collaborate with sponsors, CROs, Clinical Operations, Data Management, QA, and technical teams to gather requirements and support implementation. Support User Acceptance Testing (UAT) and validation activities to ensure solutions meet defined requirements. Apply knowledge of Good Clinical Practice (GCP), FDA 21 CFR Part 11, and GxP compliance requirements when supporting clinical trial systems.
Required Qualifications
Strong domain experience in Pharma, Clinical Research, or Clinical Trials. Hands-on business analysis experience with eSource, DDC, eCOA, ePRO, or eClinical solutions. Experience analyzing clinical study protocols, developing CRF specifications, supporting study builds, and defining data capture workflows. Experience preparing BRDs, functional specifications, user stories, workflow diagrams, and traceability matrices. Knowledge of GCP, FDA 21 CFR Part 11, and GxP compliance requirements. Experience with UAT and validation activities. Experience collaborating with sponsors, CROs, Clinical Operations, Data Management, QA, and technical teams. Preferred Qualifications / Requirements Knowledge of CDISC/SDTM standards. Knowledge of decentralized clinical trials (DCT). Salary & Benefits The hourly rates for this contract position are: $57 per hour on C2C or 1099. $50 per hour on W-2. These are maximum rates, and rate negotiation is not available. Location and Work Arrangement Remote position. Domain: Pharma / Clinical Research, which is mandatory.