Clinical Data Standards Manager IIIK3-Innovations, Inc. • New York, New York, United States
Clinical Data Standards Manager III
K3-Innovations, Inc.
- New York, New York, United States
- New York, New York, United States
Über
Data Standards Manager III
to join our Clinical Data Reporting & Standards team. This role plays a critical leadership function in ensuring clinical data standards are consistently applied across studies, from data collection through regulatory submission. The ideal candidate is a subject matter expert in CDISC standards with strong communication skills and the ability to influence cross-functional teams.
Key Responsibilities
eCRF Design
Critically review eCRF designs to ensure alignment with CDASH and SDTM standards
Identify limitations in eCRF design and proactively collaborate with study teams to resolve issues
SDTM Conformance & Mapping
Create and review SDTM conformance mapping specifications using SDTM, TAUG, and AbbVie standards
Support complex, study-specific data mapping to SDTM
CDISC Validation
Execute CDISC validation tools (e.g., Pinnacle 21)
Partner with cross-functional teams to resolve validation issues and ensure appropriate documentation of unresolved findings (e.g., Clinical Study Data Reviewer’s Guides)
Create and review Trial Design domains
Maintain a clear understanding of end-to-end traceability from data collection through reporting
Metadata Repository & Governance
Manage CDISC-related metadata, terminology, and standards within the metadata repository
Provide governance oversight to Data Standards Analysts and Senior Data Standards Analysts to ensure metadata consistency
Standards Development & Governance
Assist in the development and evolution of data standards
Guide study teams on the appropriate use of AbbVie standards and best practices
Cross-Functional Collaboration
Represent the Clinical Data Reporting & Standards group across cross-functional initiatives
Ensure industry and AbbVie standards are understood and followed
Communication & Influence
Clearly articulate clinical data standards concepts, regulatory guidance, and clinical principles
Effectively present logical, persuasive arguments to programmers, statisticians, data scientists, clinical development, and regulatory stakeholders
Diplomatically advocate for Data Standards priorities in cross-functional settings
Qualifications
MS with
8+ years
of relevant clinical research experience
OR
BS with
12+ years
of relevant experience
Expert‑level knowledge of
CDASH, SDTM, define.xml, and CDISC controlled terminology
Proven experience mapping and converting legacy data into SDTM domains for
eCTD submissions
Minimum of
two successful regulatory submissions
with CDISC‑compliant data
Strong understanding of international regulations and regulatory guidance related to clinical data standards
Hands‑on experience with
metadata repository technologies
and data standards governance
Why Join Us? This is an opportunity to make a meaningful impact on global clinical data standards while working remotely with a collaborative, highly skilled team. You’ll operate at a strategic level, influencing how clinical data is structured, governed, and delivered for regulatory success.
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Sprachkenntnisse
- English
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