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Clinical Business Analyst

Clinical Business Analyst

latinum hr solutions
Early Applicant
  • Posted 3 days ago
  • Be among the first 10 applicants

Job Description

Clinical Business Analyst

Experience: 7+ Years

Location: PAN India

CTC: Up to ₹40 LPA

Industry: Life Sciences / Pharma

Employment Type: Full-time

Key Responsibilities :

  • Clinical Metadata Repository (MDR)
  • CDISC Standards – SDTM, ADaM, CDASH & Controlled Terminology (CT)
  • Clinical data models, metadata schemas and mappings
  • Regulatory submissions and compliance – FDA / EMA
  • Clinical data standards and standards management
  • MDR-related platforms and metadata services
  • Functional understanding of technical designs and APIs
  • Data and metadata concepts with SQL read-level understanding

Tools & Documentation :

  • Jira
  • Confluence
  • MS Word & Excel
  • Figma
  • Visio
  • SQL

Preferred / Nice to Have

  • Enterprise MDR implementations
  • Large Pharma MDR / Clinical Data Standards programs
  • Standards automation
  • CDISC standards up-versioning
  • Data and metadata reuse initiatives
  • Enterprise-level metadata governance
  • Interested candidates can share their updated CV at [Confidential Information] & [HIDDEN TEXT]

    More Info

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    Industry:
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    Key Skills

    MDR-related platforms and metadata services

    Functional understanding of technical designs and APIs

    CDISC Standards – SDTM ADaM CDASH Controlled Terminology CT

    Regulatory submissions and compliance – FDA EMA

    Clinical data models metadata schemas and mappings

    Clinical data standards and standards management

    Clinical Metadata Repository (MDR)