Business Analyst (Clinical Metadata Repository / MDR)

Role Overview

We are seeking an experienced Business Analyst with expertise in Clinical Metadata Repositories (MDR) and CDISC standards to support enterprise clinical data standards and metadata management initiatives. The ideal candidate will act as a bridge between business stakeholders, clinical standards teams, and technology teams to define, manage, and optimize metadata-driven processes across the clinical trial lifecycle.

Key Responsibilities

• Gather, analyze, and document business requirements related to Clinical Metadata Repository (MDR) solutions.
• Collaborate with Clinical Data Management, Standards, Regulatory, and Technology teams to define metadata models and standards requirements.
• Support implementation and enhancement of enterprise MDR platforms.
• Work with CDISC standards including SDTM, ADaM, CDASH, and Controlled Terminology (CT).
• Define and maintain metadata mappings, data lineage, and standards governance processes.
• Participate in requirements workshops, stakeholder discussions, and solution design reviews.
• Create and maintain business requirements documents, user stories, process flows, and functional specifications.
• Support validation, user acceptance testing (UAT), and change management activities.
• Ensure compliance with regulatory requirements and industry standards for clinical data submissions.
• Collaborate with technical teams on APIs, metadata services, integrations, and data models from a functional perspective.

Required Skills & Experience

Domain Expertise

• Strong understanding of clinical trial processes and the clinical data lifecycle.
• Hands-on experience with Clinical Metadata Repositories (MDR).
• Experience working with CDISC standards:
  • SDTM
  • ADaM
  • CDASH
  • Controlled Terminology (CT)
• Knowledge of FDA and EMA regulatory submission requirements.

Technical & Analytical Skills

• Experience with metadata management, data modeling, metadata schemas, and data mappings.
• Familiarity with MDR technologies, metadata services, or graph database concepts.
• Ability to review and interpret technical designs and API specifications.
• Basic SQL knowledge for data analysis and validation.

Tools

• Jira
• Confluence
• Microsoft Excel
• Microsoft Word
• Figma
• Visio

Soft Skills

• Strong communication and stakeholder management skills.
• Excellent analytical and problem-solving abilities.
• Ability to work effectively in cross-functional and global teams.
• Detail-oriented with a structured and quality-focused approach.

Preferred Qualifications

• Experience with enterprise MDR implementations.
• Exposure to standards automation, metadata reuse, and version management initiatives.
• Prior experience in large pharmaceutical, biotech, or CRO organizations.
• Experience supporting enterprise clinical standards programs.

Education

• Bachelor''s or Master''s degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, Health Informatics, or a related field.

Experience

• 10 years of experience in Clinical Data Management, Clinical Standards, Metadata Management, or Business Analysis roles within the Life Sciences domain.