Clinical Data Standards Manager III

1. Position Title: Data Standards Analyst

2. Length of Contract: 1 year

3. Location/Site: US

4. Remote

6. The top 3-5 skills, experience or education required for this position:

• At least 5 years of SDTM experience
• SDTM annotation
• Experience with mapping from CDASH to SDTM
• Experience with SDTM submission documents aCRF, define.xml, cSDRG (clinical Study Data Reviewer’s Guide)
• P21E validation

Purpose:

Develop, implement and maintain end-to-end data standards from data collection to regulatory submission. Ensuring traceability throughout the data process and ensuring submission datasets conform to the data standards expected by regulatory agencies.

Responsibilities:

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures

• Industry Standards - 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 of eCRF design and correct flaws proactively.

• SDTM Conformance Mapping - Demonstrate 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 both SDTM and ADaM along with the associated define.xml files 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.

• 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.

• Training & Mentoring - Be compliant with training requirements. Effectively mentor peers and Data Standards Analysts with regard to 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 - Develops external reputation of a clinical data expert by actively participating in CDISC volunteer opportunities including foundational standards teams and Therapeutic Area standards teams. Provides review comments on applicable CDISC standards as they are released for public review. Submits at least one abstract per year for presentation at a CDISC Interchange.

• Accountable for ensuring submission data sets conform to the data standards expected by regulatory agencies, including traceability from data collection to submission data sets.

Qualifications:

• MS with 6 years of relevant clinical research experience

• BS with 8 years of relevant clinical research experience

• Expert level of knowledge of at least two areas of clinical data standards, and high level of knowledge in at least one additional area. Areas include CDASH, SDTM, ADaM, define.xml and controlled terminology.

• Familiarity with other clinical data standards including BRIDG, ODM and SHARE

• Experience in mapping and converting legacy data into SDTM domains for eCTD submissions.

• 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, or experience with data standards governance