Position Summary
Please apply online using a laptop or desktop computer.
Are you an asker of questions? Do you like to challenge the status quo? Do you like to work with a group to affect change and improve the quality of data by having non-ambiguous definitions of Clinical Research data, so that we have high-quality data to give to researchers who are engaging in leading-edge cellular therapy science?
This position is responsible for creating and maintaining a metadata repository in the field of Hematopoietic Stem cell Transplantation (HSCT). The primary accountabilities of this role include determining how data important for Clinical Research will be captured, researching the clinical meaning of data to be captured in the form of questions or other structures such as FHIR resources, reviewing metadata for quality, consulting with subject matter experts, performing mappings between metadata and database systems up to and including mapping to the caDSR and external clinical vocabularies such as SNOMED, LOINC, RxNorm and others.
This is a remote position (US).
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Accountabilities
Analyzes Metadata:
- Support development of business rules and best practices for metadata curation, including managing review and approval through a consensus process with work groups of cancer researchers.
- Decompose metadata issues and propose solutions and manage completion of the change; Group facilitation skills including negotiation and consensus building.
- Defines precisely the clinical meaning of questions.
- Consults with subject matter experts (SMEs) about concept definitions and curation requirements.
- Performs web-based research to determine the clinical meaning of clinical outcomes questions.
- Determines how the data for clinical outcomes questions will be captured (data type, maximum length, allowable values, etc.).
Reviews Metadata
- Prepares detailed reports of metadata using Microsoft Excel spreadsheets, proposing improvements for automation.
- Performs detailed peer reviews of metadata for quality, consistency, and reuse.
- Manages metadata content using a Knowledge Management System (Symedical).
Maps Metadata To Database Systems And Data Standards
- Develops complex mappings between metadata and database systems. Consults with developers about the incorporation of mappings into applications.
- Develop mappings for Electronic Data Capture (AGNIS, FHIR) to enable clinical research sites to submit data electronically.
- Creation and maintenance of Case Report Forms (Form Builder reports in the caDSR) supporting AGNIS end user processes.
- Determine conceptual mappings to be used in the physical mappings of data to an internal Data Warehouse (Unified Domain Model (UDM)).
- Maps data points (concepts) to industry data standards such as FHIR, MedDRA, SNOMED-CT and LOINC and others for the semantic interoperability of our clinical research data to these external standards.
Prepares And Maintains Documentation
- Prepares and reviews documentation about the metadata analysis process.
- Maintains list of frequently used concepts.
- Assists in the maintenance of reference documentation.
Develops, modifies, and maintains Common Data Elements (CDEs) in the National Cancer Institute’s (NCI) Cancer Data Standards Registry and Repository (caDSR).
- Reviews and approves reuse of existing common data elements.
- Develop more complex common data elements (CDEs) and standards.
- Develop and maintain best practices for metadata curation, including managing review and approval.
- Requires ability to work with experts in medical terminology, health data standards (FDA, HL7, CDC, CDISC), and clinical data management, as well as database designers.
Develops, modifies, and maintains field and data dictionary entries (DDCs) in the FormsNet Form Definition Manager (FDM):
- Reviews and approve reuse of existing data dictionary elements.
- Review and approve data dictionary codes (DDCs) to define data collection points.
- Associate CDEs to DDCs to ensure data harmonization.
- Finalizes field names for standardization and harmonization with prior forms revisions.
- Works with the business to determine requirements and resolve issues.
Development Of New Form Revisions
- Works with business partners to develop new collection mechanisms, but primarily forms and new form revisions.
- Ensures that clinical outcomes questions are consistent with approved standards.
- Reviews and approves the recommendation as to how questions should be stated, and answers captured.
Other Accountabilities
- Other projects and tasks as assigned by Manager.
Required Qualifications
Knowledge of:
- Proven Analytical Experience in the field of analyzing biological metadata
- Informatics, biology, or health care background required.
- Advanced knowledge of Microsoft Excel.
- Experience with the National Cancer Institute’s cancer Data Standards Registry and Repository (caDSR) tools (CDE Browser, Form Builder, Curation Tool, and the Semantic Integration Workbench) preferred.
Ability To
- Be detail-oriented with the ability to perform complex data mappings.
- Experience with the National Cancer Institute’s cancer Data Standards Registry and Repository (caDSR) tools (CDE Browser, Form Builder, Curation Tool, and the Semantic Integration Workbench) preferred.
- With assistance from senior staff, proactively understand and manage customer expectations and assess complex situations, set priorities, and implement action plans. A very strong orientation toward complete, provable, and high-quality outcomes. Strong organization skills and ability to work independently as well as collaborate on a team.
- Accept feedback constructively from multiple reviewers and able to interact with all levels of staff in the organization; ability to determine what is correct and what the repercussions are; ability to clearly articulate and defend decisions.
- Demonstrate strong written and verbal communication skills to effectively and professionally communicate with management, staff and customers as well as demonstrate sound judgment and reasoning skills.
Education And/or Experience
- Bachelor’s degree in informatics, biology, computer science, nursing, public health, or other healthcare related field. On evaluation, four years of related experience, in addition to the minimum experience, may be substituted for the degree requirement.
- Three plus years’ experience in an informatics, health care or biology position, preferably in a Clinical Data Management, Nursing, Laboratory Technician, Pharmacy Technician, Programmer, Database Analyst, Data Analyst, Metadata Analyst or Business Analyst role. Knowledge of either medical or biological terminology required.
- Two years (concurrent with above) of demonstrated Analytical Experience writing metadata and metadata standards.
PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
- Experience in metadata analysis preferred.
- Experience developing ISO 11179 compliant data standards preferred.
- Knowledge of CDISC, FHIR, and other clinical data standards preferred.
- Knowledge of SNOMED-CT, LOINC, ICD, and other clinical vocabularies preferred.
- Experience in SQL query writing
Be The Match offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits. Retirement, paid time off/holidays, leave and incentive plans are also offered to eligible employees. Please reference this link for more information: Be The Match Benefit Information
Additional Information
- Number of Openings: 1
- Pay Basis: Yearly
- Schedule: Full-time
- Driver Policy: No
- Job Family: Research & Development
- Career Category: Entry
- Career Level: 7