Clinical Data Standards Specialist

Job title: Clinical Data Standards Specialist – CDASH / CRF Annotation

Location : India (remote)

Role Overview

The client is looking for a Clinical Data Standards Specialist, not a traditional Clinical Data Manager or programmer.

The primary responsibility is to develop, implement, and maintain CDASH standards for clinical data collection and create annotated CRFs (aCRFs) based on CDASH and SDTM requirements.

Core Responsibilities

• Develop, implement, and maintain CDASH standards for clinical data collection.
• Review the clinical protocol and understand the data/form requirements.
• Create and maintain annotated CRFs (aCRFs).
• Create annotations based on CDASH and SDTM standards.
• Develop the CRF annotation/specification that will subsequently be used by the EDC/Rave build team.
• Ensure annotations are appropriate for downstream Medidata Rave implementation.
• Work with Metadata Repositories / standards libraries.
• Support maintenance and versioning of standards and metadata.
• Participate in standards governance and updates.
• Collaborate with Data Management, Programming, and EDC teams.

CDISC / Standards Requirements

Must have:

• CDASH
• SDTM knowledge
• Clinical data standards
• CRF annotation
• Annotated CRF/aCRF creation and maintenance
• Understanding of how data collection standards translate into CRF specifications
• Metadata Repository / standards library experience
• Standards maintenance and governance

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”