Job Brief: Clinical Data Modelling Specialist (USDM Expert)
We are seeking a highly skilled Clinical Data Modelling Specialist with deep expertise in the Unified Study Data Model (USDM) to support data standardization, metadata strategy, and study build processes within clinical development. The role requires strong knowledge of clinical data flows, regulatory standards, and interoperability frameworks. The specialist will work closely with Clinical Operations, Data Management, Biostatistics, and Technology teams to design, validate, and optimize USDM-based models that ensure accuracy, consistency, and compliance across clinical studies.
Job Requirements
Core Qualifications
- Bachelor’s or Master’s degree in Life Sciences, Data Science, Bioinformatics, Computer Science, or related field.
- 5+ years of experience in clinical data standards, clinical data modelling, or clinical data management.
- Proven and deep expertise in USDM (Unified Study Data Model).
Technical Expertise
- Hands-on experience with clinical data standards such as CDISC (SDTM, ADaM, ODM), HL7 FHIR, BRIDG, and related metadata models.
- Strong understanding of clinical study design, protocol elements, study metadata, and data collection structures.
- Ability to design and validate data models supporting end-to-end clinical data flow.
- Proficiency with metadata repositories, controlled terminology, and data governance principles.
Key Responsibilities
- Develop and maintain USDM-based study data models and metadata structures.
- Translate study protocol elements into standardized USDM components.
- Partner with cross-functional teams to align data capture, transformation, and submission processes with USDM.
- Validate models for accuracy, consistency, and regulatory compliance.
- Contribute to process optimization, automation initiatives, and data lifecycle improvements.
- Support integration of USDM with EDC systems, metadata repositories, and clinical platforms.
Skills & Competencies
- Strong analytical, modelling, and problem-solving skills.
- Excellent documentation and communication capabilities.
- Ability to collaborate with clinical, data, and technology teams.
- Detail-oriented approach with a strong understanding of regulatory expectations.