Clinical Data Analyst

Title: USDM Programmer / Data Standards Expert

Duration: 6 months
Extension: Possible
Location: Nationwide full remote
Work Hours: 9:00 - 5:00 local time
No travel required
No On-Call responsibilities
**Offices in San Bruno and Mountain View CA, Boston MA, Dallas TX, and Raleigh NC. If the candidate is in one of these locations and would like to sit in the office hybrid or full time, they are welcome to do so, but it is not required.

Role Overview

We are seeking a highly skilled Programmer and USDM (Unified Study Definitions Model) 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 CTMS, FHIR (both Client FHIR model and other industry implementations) and sponsor systems.

Key Responsibilities

Protocol Ingestion & Transformation

• Support the transformation of protocol data into USDM-compliant representations that can be consumed by pharma sponsors.

• Ensure accurate mapping across CTMS, FHIR (Client and industry), and sponsor systems.

Sponsor-Ready Deliverables

• Validate completeness and accuracy of 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 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.

Required Qualifications

• 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 USDM / *** MUST BE EXPERT LEVEL ***

• Hands-on experience with CTMS systems and 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 CDISC standards (SDTM, ADaM) and regulatory expectations for protocol data.

Preferred Qualifications

• 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.