Clinical Data Standards Specialist - Belgium The SDTM Expert consultant collaborates with SDTM experts from standards and submission teams in defining and implementing the updates required for the adoption of the CDISC Define-XML 2.0 version on the different layers of the existing library .
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The SDTM Expert consultant collaborates with SDTM experts from standards and submission teams in defining and implementing the updates required for the adoption of the CDISC Define-XML 2.0 version on the different layers of the existing library standards: Metadata and Data Collection.
The SDTM Expert provides implementation support to the Standards SDTM experts and Standards Librarian experts (data collection) for upgrading the library standards to CDISC SDTM 1.4 and SDTM IG 3.2 from SDTM 1.3 and SDTM IG 3.1.3.
The SDTM expert provides significant support during the overall steps of the project: from requirement to implementation, release and trial teams support.
- Takes on an active role in completing the gap analysis between the current version of the standards and the Define-XML 2.0 and SDTM 1.4, SDTM IG 3.2 requirements.
- Participates in defining the action plans and the implementation of the updates as per defined requirements in collaboration with submission and standards experts.
- Participates in completing the impact analysis on the data collection elements and define the requirements for the data collection team to implement the changes in the eDC system and applicable data collection documentation.
- Collaborates with the SDTM experts to upgrade the controlled terminology and the SDTM/SDTMIG standards in accordance with the CDISC Define-XML v2.0 Specification, SDTM V1.4/SDTMIG v3.2 definitions and Submission requirements under the supervision of the Clinical Data Standards managers.
- Collaborates with the ADaM experts from the standards analysis team to evaluate the impacts of the controlled terminology and SDTM metadata updates.
- Supports the updates to and maintenance of the corresponding IDAR processes, training material, job aids and guidelines.
- Provides guidance to IDAR staff related to the upgrades and supports the training to IDAR staff or other related departments.
This position will report to the Manager Clinical Data Standard and effectively interacts with the other members of the standards and submission teams.
Work from home: Not Allowed
No. of Positions: 1
Skills and Expertise
Desired Skills & Experience
Education level: BA/BS in life science of computer sciences
This position requires an in-depth knowledge of SDTM standards and define.xml specifications, submission processes and requirements. As well as data management processes, especially trial initiation, SDTM datasets set-up and QC and regulation compliance.
At least 5 years of working experience in standards/data management/programming and significant knowledge of CDISC SDTM 1.4, SDTM IG 3.2, CDISC Controlled Terminology and basic knowledge of CDISC Define-XML is a must.
Knowledge of CDISC Define-XML v 2.0 and data collection tools requirements is a plus.
Very good collaboration, supporting and communication skills are also required.