Data Standards Manager

South Plainfield, NJ, US • Posted 13 days ago • Updated 12 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Management
Meta-data Management
Data Collection
Cross-functional Team
Reporting
Communication
Clinical Research
XML
Mapping
SDTM
CDISC
Data Dictionary

Summary

Roles and Responsibilities:

eCRF Design - Able to critically review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards. Recognizes limitations in eCRF design and works with the study team to correct flaws proactively.
SDTM Conformance Mapping - Create and Reviews SDTM conformance mapping specifications applying SDTM, TAUG and Client standard.
CDISC Validation Tools - Executes validation tools (e.g., Pinnacle 21) and collaborates with other functions to resolve identified issues. Ensure any unresolved issues are appropriately documented (e.g., Clinical Study Data Reviewer's Guides).
Create and review Trail Design domains
Clear understanding of End-to-end traceability from Data Collection to Data reporting.
Metadata Repository - Responsible for managing libraries of CDISC-related metadata, terminology, and related standards within the metadata repository. Provides governance oversight to Data Standards Analyst and Sr Data Standards Analyst to ensure consistency in metadata.
Standards Development - Assist in the development of data standards.
Standards Governance - Provide guidance to study team members on the appropriate use of Client's standards. Consult on complex study-specific data collection and mapping to SDTM.
Cross-functional Team Participation - Represents the Clinical Data Reporting & Standards group to ensure industry and Client standards are followed and understood.
Communication - Clearly communicates an understanding of clinical data standards concepts, clinical principles, and regulatory guidance and acts in accordance with those principles. Effectively presents data standards concepts and logical arguments to statistical programmers, statisticians, data scientists, clinical development and regulatory study team members. Able to diplomatically and persuasively represent the interests of the Data Standards group in cross-functional initiatives.

Education & Experience:

MS with 8 years of relevant clinical research experience (or BS with 12 years relevant experience).
Expert level of knowledge of CDASH, SDTM, define.xml and controlled terminology.
Experience in mapping and converting legacy data into SDTM domains for eCTD submissions. Minimum of two successful submissions of CDISC compliant data.
Knowledge of international regulations, requirements and guidance associated with clinical data standards and the preparation of data sets for regulatory submission.
Experience with metadata repository technology and its application in clinical data standards processes and experience with data standards governance.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: ee7395485445a792fd1558f53602d4d5
Posted 13 days ago

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Data Standards Manager

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Job Details

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