Archimedis Digital - Business Analyst - Clinical Data

- Requirements Elicitation and Analysis: Gather, analyze, and document detailed business and functional requirements for clinical data management systems, including but not limited to Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and Electronic Trial Master Files (eTMF).

- Stakeholder Liaison: Act as a primary point of contact and effectively liaise between business stakeholders (e.g., Clinical Operations,

- Data Management, Biostatistics), IT development teams, and Quality Assurance (QA) teams to ensure clear communication and alignment on project goals and requirements.

- GxP Validation Support: Provide active support in computer system validation (CSV) activities within a GxP regulated environment, including the creation and review of User Requirements Specifications (URS), Requirements Traceability Matrices (RTM), and User

- Acceptance Testing (UAT) protocols and reports.

- Process Improvement: Assist in process mapping current and future state workflows related to clinical data management, identify areas for improvement, and contribute to the development of more efficient and effective processes.

- Data Analysis: Participate in data analysis activities to understand data flows, identify data quality issues, and contribute to the development of data migration or integration strategies.

- Documentation: Prepare high-quality and comprehensive business requirements documents (BRDs), functional specifications documents (FSDs), and user stories with clear and testable acceptance criteria.

- Requirements Management: Facilitate requirements gathering sessions with stakeholders, document meeting minutes, and ensure that all requirements are clearly understood, documented, and approved.

- System Design Collaboration: Participate in system design discussions with IT teams to ensure that the proposed technical solutions meet the documented business and functional requirements.