Overview
On Site
Full Time
Skills
Data Mapping
Data Management
Regulatory Compliance
Data Warehouse
Meta-data Management
Policies and Procedures
Communication
Training
Mentorship
Management
Presentations
XML
Oracle Data Mining
Object Data Manager
Mapping
SDTM
CDISC
Data Dictionary
Job Details
Responsibilities:
- 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.
- ble 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.
- ble 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.
- Expert level of knowledge of at least three areas of clinical data standards, and high level of knowledge in at least one additional area.
- reas include CDASH, SDTM, ADaM, define.xml and controlled terminology. SDTM expertise is required.
- Familiarity with other clinical data standards including BRIDG, ODM and SHARE.
- 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.
- Experience in supporting the development of standard procedures, guidelines and templates.
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