Overview
Skills
Job Details
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