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 (Mumbai)
🏢 Mindlance
📍 Mumbai