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 Chance Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”

📌 Clinical Data Standards Specialist (India)
🏢 Mindlance
📍 India