Clinical Data Modeler

iO associates are supporting a life sciences consultancy with a US-based clinical development contract focussed on a foundational data architecture initiative building a semantic clinical data layer that enables consistent, standards-based integration of clinical trial and biometrics data across studies, systems, and data sources.

This is not a traditional clinical data management role. The work sits upstream of analytics and reporting and requires deep expertise in clinical data standards, ontologies, and semantic modeling.

Key Responsibilities

• Design and build clinical data ontologies to support harmonization across protocol and non-protocol data

• Develop and maintain a semantic data model connecting clinical, biometrics, and operational data across multiple studies

• Apply and extend industry standards including CDISC (SDTM/ADaM), HL7 / FHIR Bridge, and OMOP to enable interoperability

• Translate clinical protocol concepts into consistent, reusable semantic representations

• Partner closely with clinical data management, biometrics, and informatics teams to ensure alignment and usability

• Support cross-study and cross-program consistency while accommodating therapeutic and protocol-level variation

• Contribute to governance, documentation, and best practices for semantic modeling and standards adoption

Required Experience

• Strong hands-on experience as a clinical semantic data modeler, clinical data architect, or ontology specialist

• Proven track record building or implementing clinical data ontologies (not just mapping or transformation work)

• Deep working knowledge of clinical data standards such as:

  • CDISC (SDTM, ADaM)

  • HL7 / FHIR (including bridge or interoperability layers)

  • OMOP / OHDSI (or similar common data models)

• Experience integrating data across multiple clinical studies and heterogeneous data sources

• Strong understanding of clinical trial data flows, from protocol design through biometrics and analysis

Get in touch to apply, e.hincks @ioassociates.com