Data Standards Manager III

Join to apply for the Data Standards Manager III role at Katalyst CRO

3 days ago Be among the first 25 applicants

Join to apply for the Data Standards Manager III role at Katalyst CRO

Get AI-powered advice on this job and more exclusive features.

• Maintains complete and in-depth understanding of all CDISC guidance documents and implementation guides as well as FDA guidance and regulation regarding electronic submission of data.
• Keeps abreast of industry trends in data mapping, data management, standards compliance methodologies, metadata management and data warehousing.
• eCRF Design - Demonstrates extensive understanding of CDASH and SDTM standards and concepts.
• Able to critically review eCRF designs to ensure compatibility / conformance with CDASH / SDTM standards.
• Recognizes limitations if eCRF design and correct flaws proactively.
• SDTM Conformance Mapping - Demonstrate extensive understanding of SDTM, Standard Terminology and common coding dictionaries.
• Reviews SDTM conformance mapping specifications and corrects flaws proactively.
• CDISC Validation Tools - Demonstrates knowledge of rules for SDTM and the associated define.xml file or rules for ADaM and the associated define.xml file and able to appropriately interpret results from common validation tools.
• Executes validation tools and collaborates with other functions to resolve identified issues.
• Ensure any unresolved issues are appropriately documented (for example in the FDA?s Data Reviewer?s Guides).
• 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.
• Policies & Procedures - Assist in the development of data standards policies, procedures and practices.
• 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.
• Able to diplomatically and persuasively represent the interests of the Data Standards group in cross-functional initiatives.
• Training & Mentoring - Effectively mentoring peers on the Data Standards team regarding data standards and functional operations.
• Train new Data Standards Analysts on process and systems related to the management and implementation of data standards.
• CDISC involvement - Maintains external reputation of a clinical data standards expert.
• Ensures consolidated review comments from Data Standards group and Statistical Programming are provided for applicable CDISC standards released for public review.
• Submits at least one abstract per year for presentation at a CDISC Interchange.

Responsibilities

Requirements :

Seniority level

Seniority level

Associate

Employment type

Employment type

Contract

Job function

Job function

Information Technology

Industries

Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Katalyst CRO by 2x

Get notified about new Standards Manager jobs in North Chicago, IL

Clinical Quality Documentation Specialist, Full-time, Days, Hybrid ($4,000 sign-on bonus)

Director Global Quality Management System

Director, Standards Development & Program Management

North Chicago, IL $106,500.00-$202,500.00 1 week ago

Arlington Heights, IL $70,000.00-$110,000.00 3 weeks ago

Regional Safety Health & Environmental Manager

Standards Project Manager (Appliances, HVAC, and Lighting)

Evanston, IL $67,319.32-$92,564.06 1 week ago

Sustainability Resilience Manager - Building Performance Standards Program

Evanston, IL $94,819.11-$142,229.27 5 days ago

Elk Grove Village, IL $22.00-$24.00 1 week ago

Morton Grove, IL $160,000.00-$180,000.00 2 weeks ago

Des Plaines, IL $100,000.00-$130,000.00 4 days ago

Lead Standards Project Manager - Software-Enabled Products, Autonomy & Robotics (SEPAR)

Evanston, IL $98,562.21-$135,523.05 1 week ago

Kenosha, WI $55,000.00-$65,000.00 2 weeks ago

Senior Process Engineer - Medical Film Converting

Lab Quality Manager for Moderate Complexity CLIA Lab

Des Plaines, IL $115,000.00-$129,000.00 5 days ago

Northbrook, IL $125,000.00-$125,000.00 2 months ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

J-18808-Ljbffr