Job Description

Reference # : 17-12569Title : Harmonization of Common Data Models and Open Standards for Evidence Generation
Location : St Louis
Position Type : Contract
Experience Level : Start Date / End Date : 12/12/2017 / 12/31/2017
Assignment Detail
Industry:GovernmentJob Category:IT Operations / Infrastructure

Harmonization of Common Data Models and Open Standards for Evidence Generation

Eclaro is looking for a Harmonization of Common Data Models and Open Standards for Evidence Generation for an opportunity for our client in St Louis, MI.

In order to achieve a sustainable data network infrastructure, promote interoperability and foster the creation of a Learning Health System (LHS) as laid out in the Connecting Health and Care for the Nation a Shared Nationwide Interoperability Roadmap1, there is a need to map and transform data across various Common Data Models (CDMs) and leverage open-source standards. By mapping various CDM data elements and leveraging existing Patient-Centered Outcomes Research Trust Fund (PCORTF) investments, it is feasible to reuse the data, methods and other resources from each network (e.g., PCORNET, Sentinel, Observational Health Data Sciences and Informatics (OHDSI), i2b2) thereby providing Patient-Centered Outcomes Research (PCOR) researchers with access to larger and more diverse types of Real World Data (RWD).
This PCORTF project is a collaboration of several Health and Human Services (HHS) agencies including FDA, National Institutes of Health (NIH) (National Cancer Institute (NCI), National Center for Advancing Translational Sciences (NCATS), National Library of Medicine (NLM)), and the Office of the National Coordinator (ONC)). There is an overarching plan outlining the responsibilities of each agency. This statement of work includes only activities where FDA is responsible.
This project will build upon existing Office of the Secretary (OS) PCORTF investments and other HHS investments. While each of these investments help to make data accessible and understandable, each addresses specific data sources, representing not just specific data models but also specific collection use cases and constraints. This project is aimed at leveraging existing PCORTF investments, including the Data Access Framework (DAF), NIH Common Data Elements (CDE) Repository, and the NCI cancer Data Standards Registry and Repository, which can help with building reusable data mapping and transformation services.
To test and demonstrate the value of the project's approach, following mapping the CDMs, the observational data identified by means of the resulting CDM will be utilized to evaluate factors associated with the safety and effectiveness of newly approved oncology drugs in combination with other immunotherapy agents.
The data models from each of the Input CDMs (i.e., Sentinel, Observational Health Data Sciences and Informatics (OHDSI), National Patient-Centered Clinical Research Network (PCORnet), Informatics for Integrating Biology and the Bedside (i2b2)) will be mapped to one common model. Currently the Biomedical Research Integrated Domain Group (BRIDG) model is being proposed, although a model that meets the requirements of the one common model (e.g., is publically available, is consensus based, accommodates the output standards (Clinical Data Interchange Standards Consortium (CDISC), Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR)) could be considered. An Extract-Transform-Load (ETL) tool that meets the project's requirements will be selected and used to map the Input CDMs to the common model. In this statement of work, it is referred to as a "tool? since the tool evaluation is underway. The result is that a researcher would be able to pose a research question through a portal leveraging the data available from the Input sources. In addition, participating Agencies will leverage the common model to create data in standardized format (e.g., CDISC) for use by regulatory experts.

The purpose of the FDA Harmonization of Common Data Models project is to:
  • Develop a data integration architecture to capture real-world data from healthcare providers and other sources to assess the effectiveness and safety of regulated medications and medical devices
  • Build a prototype data integration system to convert data from up to 4 data repositories containing such real-world data into a common data model (BRIDG ? Biomedical Research Integrated Domain Group), via an Extract-Transform-Load (ETL) platform.
  • Implement ETL to transform data from the BRIDG target data model to multiple message types that support FDA data standards for clinical trials
  • Develop a white paper describing how other Patient-Centered Outreach (PCOR) investments across HHS could be integrated with this data model harmonization project after successful proof of concept.

Data Architect/ETL Developer Responsibilities
The Data Architect/ETL Developer will write and test data integration code using mapping specifications provided by FDA, to convert data from up to four source formats defined by existing repositories of real-world evidence, into a common target model, BRIDG. They will work with a technical team at the National Center for the Advancement of Translational Sciences (NCATS) to prepare a prototype data integration system to produce H7 and CDISC SDTM message types, adhering to FDA standards.
Experience in data management and ETL concepts is more important than familiarity with any specific tool, although knowledge of Adeptia (tool selected by FDA) would be beneficial. Experience with clinical healthcare data is desired.

Required Skills
  • 10+ Years of software development experience
  • 5+ Years of ETL development experience
  • Lifesciences and healthcare experience, especially having a practical working experience with patient data and good understanding of regulatory compliance in that space
  • Understanding of the observational research process
  • Understanding of at least one of the common data models and networks (Sentinel, OMOP, OHDSI, ACT/i2b2)
  • Electronic Data Interchange (EDI) and B2B skills (cross-organization integration, independent from any technology)
  • Data modeling, data integration
  • Knowledge of Oracle database setup and administration to assist the Samvit team

ECLARO is a company that delivers talent. We provide fully customizable, comprehensive talent acquisition and management of seasoned professionals through a number of business models, including: Consulting, Professional Hire, Global Integrated DeliveryTM and Managed Services. ECLARO recruits and manages a staff of highly skilled individuals in an array of specialized disciplines. This approach enables our clients to leverage new opportunities, respond to increased and changing demands and increase their profitability. Please visit to see why the Right People are The AnswerTM.

Specialties: Customized solutions for Human Capital and Talent Acquisition, Permanent placement and retained search, Recruiting, Staff Augmentation, Contract Labor, Managed Services, RPO, MSP, VMS, IT solutions, management and support, offshore business process outsourcing.

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Industry: Staffing and Recruiting
Type: Privately Held
Company Size: 501-1000 employees
Founded: 1999

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