Location: Pune, Maharashtra, India (Remote/Hybrid)
Company: Cytel Inc.
Job ID: 1369
Job Type: Full-Time
Experience Required: 5–8 years (Not suitable for freshers)
About the Company
Cytel Inc. is a globally recognized leader in biostatistics, advanced analytics, and clinical research solutions. The organization supports pharmaceutical and biotechnology companies in accelerating clinical development through data-driven innovation, statistical expertise, and cutting-edge technology.
Job Overview
The Clinical Data Engineer – USDM Specialist serves as a subject matter expert in the implementation and advancement of Unified Study Definition Model (USDM) standards. This role is central to enabling digital protocol generation, structured study design, and seamless digital data flow across the clinical development lifecycle. The position requires a blend of clinical domain expertise, data modeling skills, and strategic leadership to drive digital transformation initiatives.
Key Responsibilities
USDM Strategy & Implementation
Act as the organizational expert for Unified Study Definition Model (USDM) standards
Lead adoption and operational execution of USDM for digital protocol authoring
Translate study protocols into structured, standards-driven digital formats
Ensure alignment with global data standards such as CDISC and regulatory frameworks
Digital Protocol Generation
Drive USDM-based digital protocol generation processes
Convert narrative clinical protocols into machine-readable, structured data
Enable integration of protocol data into EDC, CTMS, regulatory, and analytics systems
Support metadata-driven workflows and automation initiatives
Digital Data Flow (DDF) Enablement
Apply Digital Data Flow (DDF) principles across the clinical development lifecycle
Map upstream study definitions to downstream operational systems
Eliminate redundant data entry and improve data reuse efficiency
Collaborate with technology teams to ensure interoperable and traceable workflows
Biomedical Concept Modeling
Model study objectives, endpoints, procedures, and assessments using structured frameworks
Ensure consistency in biomedical concept representation within USDM
Collaborate with clinical and scientific stakeholders for validation
Promote standardization using controlled vocabularies and terminologies
Cross-Functional Collaboration & Consulting
Provide expert consultation on structured protocol design and standards implementation
Collaborate with Clinical Development, Data Management, Biostatistics, Regulatory, and IT teams
Represent the organization in industry forums and standards working groups
Conduct internal training sessions on USDM and Digital Data Flow
Process Optimization & Innovation
Identify process gaps in protocol authoring and data workflows
Develop internal governance frameworks, SOPs, and best practices
Stay updated with evolving USDM, CDISC standards, and regulatory guidelines
Contribute to enterprise-level digital transformation initiatives
Required Qualifications
Education
Bachelor’s degree in Life Sciences, Biomedical Sciences, Health Informatics, Computer Science, or related field
Advanced degree (Master’s/PhD) preferred
Experience
5–8 years of experience in clinical data management, clinical systems, or digital protocol development
Proven expertise in Unified Study Definition Model (USDM) standards
Strong understanding of Digital Data Flow (DDF) concepts and implementation
Experience with CDISC standards including SDTM, ADaM, and CDASH
Hands-on experience in structured protocol authoring or metadata-driven systems preferred
Key Skills & Competencies
Strong analytical thinking and systems-oriented approach
Ability to translate complex clinical and scientific concepts into structured data models
Excellent communication and stakeholder management skills
Strategic mindset with a focus on innovation and process improvement
Expertise in documentation, governance, and standards compliance
Why This Role Matters
This position sits at the intersection of clinical research, data science, and digital transformation. Professionals in this role contribute directly to improving clinical trial efficiency, reducing redundancy, and enabling faster regulatory submissions through standardized, reusable data frameworks.
Equal Opportunity Statement
Cytel Inc. is an Equal Employment Opportunity employer. All qualified applicants will receive consideration without regard to race, religion, gender, age, disability, or any other protected characteristic.
How to Apply
Apply directly through the company’s official careers page or explore more verified global opportunities on ThePharmaDaily.com, your trusted platform for pharmacovigilance, clinical research, and healthcare careers.
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