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21 CFR Part 11•GDPR•ICH-GCP•Admin

Data Management

Clinical Data Manager

Design and manage clinical databases that meet 21 CFR Part 11 and CDISC standards.

Data Management New Delhi, IndiaFull-time4+ years

Responsibilities

Build and validate EDC databases and edit checks.
Oversee data cleaning, reconciliation and lock.
Ensure CDISC (SDTM/ADaM) compliance.
Collaborate with biostatistics and clinical teams.

Requirements

Degree in Life Sciences, Statistics or IT.
4+ years in clinical data management.
Experience with major EDC platforms.
Knowledge of 21 CFR Part 11 and CDISC.

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