MDR Business Analyst

Role-  MDR Business Analyst

Experience: 10–15 years

Location: USA, (Remote) 

Required Skills & Competencies

Domain & Functional

• Strong understanding of clinical trial processes and data lifecycle
• Hands‑on experience with:
• Clinical Metadata Repositories (MDR)
• CDISC standards (SDTM, ADaM, CDASH, CT)
• Knowledge of regulatory submissions and compliance (FDA, EMA)

Technical & Analytical

• Experience working with data models, metadata schemas, and mappings
• Familiarity with MDR‑related platforms or technologies (e.g., graph DBs, metadata services)
• Ability to read and collaborate on technical designs and APIs (functional perspective)

Tools

• Requirements & documentation: Jira, Confluence, Word, Excel
• Design & validation: Figma, Visio
• Data & metadata concepts: SQL (read‑level understanding preferred)

Soft Skills

• Excellent communication and stakeholder management skills
• Strong analytical and problem‑solving mindset
• Ability to work in cross‑functional, global teams
• Detail‑oriented with a structured, quality‑first approach

Preferred / Nice to Have

• Experience working on enterprise MDR implementations
• Exposure to standards automation, up‑versioning, or data reuse initiatives
• Prior experience with large pharma MDR or standards programs.