Description
About the Role:
The CDP-II is responsible for the design, development, programming, validation, and maintenance of clinical trial databases throughout the study lifecycle. This includes clinical database build, Case Report Form (CRF) design, edit check programming, custom function development, external data integrations, data review listings, and data reconciliation activities. The CDP-II ensures all deliverables comply with company SOPs, ICH-GCP, CDISC standards, and applicable regulatory requirements while supporting high-quality clinical data management.

Responsibilities:
- Design, build, validate, test, and maintain clinical trial databases using Medidata Rave, Veeva Vault EDC, and Viedoc EDC platforms in accordance with sponsor requirements and organizational standards.
- Develop and maintain CRFs (Case Report Forms) based on study protocols and annotated CRFs, ensuring adherence to CDISC/CDASH or sponsor-specific standards.
- Configure and program edit checks, derivations, custom functions, dynamic forms, visit structures,



and workflow logic to ensure data quality and protocol compliance.
- Develop and maintain custom functions, custom calculations, and automated data validation logic to support complex study requirements.
- Perform external data integrations (e.g., Central Labs, ECG, ePRO/eCOA, IRT/RTSM, imaging, wearable devices, and other third-party vendor data), including defining and validating data transfer specifications and coordinating with external vendors.
- Program and maintain data review listings, reconciliation reports, and discrepancy management reports to support ongoing clinical data review and cleaning activities.
- Validate clinical databases through unit testing, integration testing, User Acceptance Testing (UAT), and database maintenance activities while ensuring complete documentation.
- Ensure all programming activities are performed in accordance with company SOPs, Positive Clinical Practice (ICH-GCP), and Good Programming Pr

📌 Clinical Data Programmer II (India)
🏢 Novotech
📍 India