**Duration: 6 Months** **Job Description:** + The client is seeking a highly skilled Unified Study Definitions Model (USDM) Subject Matter Expert to provide significant domain expertise, drive data mapping between standards, and help define data mapping processes. + This role will be critical in supporting the design and implementation of processes that transform study protocols into USDM-compliant representations, enabling interoperability across Clinical Trial Management System (CTMS), Fast Healthcare Interoperability Resources (FHIR) and sponsor systems. **Responsibilities:** + **Protocol Ingestion & Transformation:** + Support the transformation of protocol data into Unified Study Definitions Model (USDM)-compliant representations that can be consumed by pharma sponsors. + Ensure accurate mapping across Clinical Trial Management System (CTMS), Fast Healthcare Interoperability Resources (FHIR), and sponsor systems. + **Sponsor-Ready Deliverables:** + Validate completeness and accuracy of Unified Study Definitions Model (USDM) outputs against protocol source documents. + Package and deliver USDM representations in formats directly usable by pharma companies. + Act as a subject matter expert in explaining how sponsor protocols map into USDM. + **Data Model Mapping:** + Lead efforts to map internal CTMS models → FHIR → USDM, ensuring interoperability. + Build robust pipelines that maintain traceability from PDF protocol → FHIR → USDM. + Define standards, templates, and validation checks to ensure consistency across studies. + **Standards & Process Leadership:** + Serve as the internal authority on Unified Study Definitions Model (USDM) concepts (elements, metadata, best practices, processes). + Guide prioritization of protocol concepts most critical to sponsors and regulators. + Collaborate with Product, Engineering, and other cross-functional stakeholders to align protocol digitization workflows with regulatory and industry standards. **Experience (Mandatory):** + 5–7 years of experience in clinical data standards, data management, or programming within pharma/biotech/clinical research. + 2–3 years of hands-on experience with Unified Study Definitions Model (USDM). + Hands-on experience with Clinical Trial Management System (CTMS) systems and Fast Healthcare Interoperability Resources (FHIR) standards, including data model mapping. + Practical experience in document parsing, text mining, or NLP/AI for unstructured data ingestion. + Strong communication skills, with ability to interface directly with pharma sponsors and explain technical mappings + Experience validating structured outputs against sponsor and regulatory requirements. + Knowledge of clinical data interoperability frameworks and submission standards. + Strong Expertise in Clinical Data Interchange Standards Consortium (CDISC) standards (Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM)) and regulatory expectations for protocol data. **Experience (Desired):** + Experience with protocol digitization initiatives in pharma/biotech/clinical research. + Strong programming background (Python, SQL, or equivalent) with experience in ETL pipelines and data transformations. **Education:** + Bachelor’s Degree or equivalent experience. **About US Tech Solutions:** **US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com (http://www.ustechsolutionsinc.com) .** **US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.**