Data Standards Manager

Katalyst CRO; SOUTH PLAINFIELD (NJ); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO seeks a Data Standards Analyst to ensure CDASH/SDTM compliance across eCRF designs and data mappings to support regulatory submissions.

You will lead SDTM conformance mappings, run Pinnacle 21 validations, manage metadata repositories, and provide governance for data standards within cross-functional study teams.

Qualifications

• Must have MS with 8 years of clinical research experience or BS with 12 years.
• Expert level knowledge of CDASH, SDTM, define.xml and controlled terminology.
• Experience mapping legacy data into SDTM domains for eCTD submissions.
• Minimum of two CDISC compliant data submissions.
• Knowledge of international regulations and data standards governance.

Responsibilities

• Review eCRF designs for CDASH/SDTM compliance.
• Identify and remediate eCRF design limitations with study teams.
• Create and review SDTM conformance mappings.
• Run validation tools (e.g., Pinnacle 21) and resolve issues.
• Document unresolved issues in the Clinical Study Data records.
• Manage libraries of CDISC metadata in the repository.
• Support governance and development of data standards.
• Advise cross-functional teams on proper use of Client standards.
• Present data standards concepts to programmers, statisticians, and regulatory teams.
• Represent Data Standards in cross-functional initiatives.

Skills

eCRF Design

SDTM Mapping

CDISC Validation

Metadata Repository

Standards Governance

Cross-functional Collaboration

Data Standards Communication

Education

MS in Clinical Data Science

BS in a related field

Tools

Pinnacle 21

Metadata Repository Tools

Job description

• 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
• 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.

Roles & 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
• 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.

Requirements

• 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.