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Job Details

Skills

: Clinical Metadata Repository (MDR)
CDISC Standards (SDTM
ADaM
CDASH
Controlled Terminology)
Clinical Trial Data Lifecycle
Regulatory Compliance (FDA
EMA)
Metadata Management
Data Modeling
Metadata Schemas
Data Mapping
MDR Platforms
Metadata Services
Graph Databases
API Collaboration
SQL
Jira
Confluence
Figma
Visio
Requirements Gathering
Business Analysis
Stakeholder Management
Functional Analysis
Standards Automation
Metadata Versioning
Data Reuse
Clinical Data Standards.

: Clinical Metadata Repository (MDR)
CDISC Standards (SDTM
ADaM
CDASH
Controlled Terminology)
Clinical Trial Data Lifecycle
Regulatory Compliance (FDA
EMA)
Metadata Management
Data Modeling
Metadata Schemas
Data Mapping
MDR Platforms
Metadata Services
Graph Databases
API Collaboration
SQL
Jira
Confluence
Figma
Visio
Requirements Gathering
Business Analysis
Stakeholder Management
Functional Analysis
Standards Automation
Metadata Versioning
Data Reuse
Clinical Data Standards.

Summary

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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91163707
Position Id: 9005788
Posted 29 days ago

Company Info

About Siro Clinpharm Pvt Ltd

Founded in 1996 as the SIRO Research Foundation and incorporated in 2000 as SIRO Clinpharm Private Limited, SIRO brings over two decades of exceptional project management expertise to the table. From pioneering proof-of-concept trials to managing complex, multinational studies involving rare diseases, stringent protocols, and accelerated timelines, SIRO has consistently delivered with precision and reliability. Our win-win philosophy drives us to ensure success for every client. Today, SIRO stands as a leading provider of drug development and discovery solutions, offering a diverse and innovative suite of CRO services to global biotech, pharmaceutical, medical device, and academic institutions. To better serve our clients’ evolving needs, we have strategically reorganized into three specialized entities: SIRO Clintech, SIRO Medical Writing, and SIRO Clinpharm, which continues to offer specialized FSP services.

Business Analyst – Clinical Metadata Repository (MDR)

Remote

•

2d ago

Job title : Business Analyst Clinical Metadata Repository (MDR) Location : Remote Required Skills & Competencies Domain & Functional Strong understanding of clinical trial processes and data lifecycleHandson 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 mappingsFamiliarity with MDRrelated platforms or technolog

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Role Overview

Key Responsibilities

Required Skills & Experience

Domain Expertise

Technical & Analytical Skills

Tools

Soft Skills

Preferred Qualifications

Education

Experience

Business Analyst (Clinical Metadata Repository / MDR)

Siro Clinpharm Pvt Ltd

Job Details

Skills

Summary

Role Overview

Key Responsibilities

Required Skills & Experience

Domain Expertise

Technical & Analytical Skills

Tools

Soft Skills

Preferred Qualifications

Education

Experience

Company Info

About Siro Clinpharm Pvt Ltd

Dice Job Match Score™

Akhilesh Mishra

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