USDM Clinical Data Specialist
US Tech Solutions
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Job summary
Qualifications
- 5–7 years in clinical data standards, data management, or programming within pharma/biotech/clinical research.
- 2+ years of hands-on experience with USDM implementation and mapping.
- Practical knowledge of CTMS systems and FHIR data standards.
Responsibilities
- Lead the transformation of clinical study protocols into USDM-compliant representations.
- Validate and deliver USDM outputs to pharma sponsors in sponsor-ready formats.
- Define and maintain standards, templates, and validation rules for consistent data representation.
Skills
Job description
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This range is provided by US Tech Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
$100.00/hr - $120.00/hr
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- Lead the transformation of clinical study protocols into USDM-compliant representations.
- Validate and deliver USDM outputs to pharma sponsors in sponsor-ready formats.
- Define and maintain standards, templates, and validation rules for consistent data representation.
- Act as the subject matter expert on USDM, guiding internal teams on best practices and critical protocol concepts.
- Collaborate cross-functionally with Product, Engineering, and Clinical Operations to align digitization workflows with industry standards.
- 5–7 years in clinical data standards, data management, or programming within pharma/biotech/clinical research.
- 2+ years of hands-on experience with USDM implementation and mapping.
- Practical knowledge of CTMS systems and FHIR data standards.
- Experience in data model mapping and validating structured outputs against sponsor/regulatory requirements.
- Strong understanding of clinical data interoperability and CDISC standards (SDTM, ADaM).
- Excellent communication skills with the ability to explain technical mappings to non-technical stakeholders.
- Familiarity with Python, SQL, or other scripting languages for data processing and ETL workflows.
- Clinical Data
- USDM
- FHIR
- Python, SQL
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.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Internal Id: 25-47502
- Mid-Senior level
- Contract
- Research
- Industries
- IT Services and IT Consulting
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