Ontology Specialist – Digital Data Flow (Clinical Research) Consultant

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

ProPharma is seeking an experienced Ontology Specialist to support the acceleration of Digital Data Flow initiatives. This role focuses on enhancing clinical trial data interoperability through ontology engineering, controlled terminology, and alignment with industry standards.

Key Responsibilities

• Apply ontology expertise to clinical trial design and metadata modeling.
• Map protocol content to the USDM 4.0 data model and contribute to its extension.
• Design semantic bindings using standardized vocabularies (e.g., SNOMED, LOINC, MedDRA).
• Develop modular, federated ontologies for clinical research.
• Align data standards across systems (e.g., EDC, CTMS) using FHIR, HL7, JSON/XML.
• Facilitate workshops to align stakeholders on structured data design.
• Participate in governance processes and standards bodies (e.g., CDISC, HL7).
  
  

Qualifications

• Experience in clinical research or working with CROs.
• Strong understanding of clinical trial phases, design, and documentation.
• Proficiency in USDM 4.0 and related CDISC standards.
• Familiarity with ICH M11 and CPT protocol templates.
• Knowledge of controlled terminology standards and ontology concepts.
• Experience in information architecture and data standards alignment.
  
  

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***