Clinical Data Standards Specialist (Medidata Rave)

Key Requirements:

- Strong experience inclinical data standards, including CDASH, SDTM, controlled terminology, and CRF annotation.
- Hands-on experience creating and maintainingannotated CRFs (aCRFs) and mapping data collection standards to CDISC requirements.
- Experience using Medidata Rave Architect to create and maintain form annotations and support standards implementation.
- Ability to translate protocol and standards requirements into study-specific annotation specifications.
- Experience working withMetadata Repositories (MDRs) and standards governance processes.
- Support review of CRFs, database specifications, edit checks, and standards compliance across studies.
- Collaborate with Data Management, Standards, Programming, and EDC teams to ensure consistent implementation of standards.
- Support standards maintenance, impact assessments,



and change control activities.

Preferred Experience:

- Experience with standards libraries and metadata management.
- Experience supporting global clinical studies and sponsor standards initiatives.

Strong communication and collaboration skills, with the ability to mentor and guide study teams on standards implementation.

Benefits:

- Adaptable schedule
- Paid sick time
- Provident Fund

Application Question(s):

- How many years of hands-on experience do you have with Medidata Rave Architect?
- Have you personally created or maintained annotated CRFs (aCRFs)?
- How many years experience with CDASH, SDTM, and CDISC ?

Experience:

- Clinical Data Standards?: 5 years (Required)

Work Location: Remote

📌 Clinical Data Standards Specialist (Medidata Rave) (India)
🏢 Exelo Technologies
📍 India