The Senior Business Analyst will be an integral part in the development of the new generation of Clinical Trial Management Systems (CTMS). These systems will simplify the operations and management of clinical trials. The goal is to help reduce the cost and accelerate the speed to market for key treatments. This, in turn, will enable us to reach more patients in need, and faster than ever before. You will interface with industry experts, product managers, engineers, project managers, architects, UX/UI, and domain experts to help drive innovation within a range of Medidata’s CTMS offering. The product is built primarily for external users and also integrates with other Medidata offerings to meet oversight and monitoring of the end-to-end activities in any clinical trial. You will report to the Senior Director, Product Management., Research & Discovery
- Research market trends, client needs, and industry regulatory standards to inform CTMS feature development.
- Lead stakeholder discovery sessions to capture pain points and translate complex business needs into system requirements.
Requirements & Solution Delivery
- Define and document functional/non-functional requirements, user stories with clear acceptance criteria, and process maps.
- Partner with Product Managers, other BAs, and cross-functional teams to integrate CTMS solutions across Medidata’s clinical technology suite.
- Collaborate with Architecture, Engineering, QA, and Tech Writing throughout build, configuration, testing, and release cycles.
Product Quality & Support
- Ensure deliverables align with technical specifications, quality standards, and defect-resolution workflows.
- Serve as a CTMS subject matter expert, supporting product launches, upgrades, and post-release enhancements.
Team Operations & Knowledge Sharing
- Active participation in Agile ceremonies, providing timely progress updates and risk escalations.
- Document architectural decisions, resolution logs, and maintain team knowledge-sharing to elevate overall capability.
Qualifications & Experience
- Bachelor’s degree (in a technical, quantitative or business discipline, e.g. business administration, management information systems, computer science, engineering, or related field)
- At least 5 years of Business Analyst or Product Management experience required in the clinical trial arena.
- Experience managing complex processes involving many stakeholders and competing priorities.
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