Senior Clinical Data Programmer (Bengaluru)

Senior Clinical Data Programmer (Bengaluru)

16 Aug
|
Novotech Global
|
Bengaluru

16 Aug

Novotech Global

Bengaluru

About the Role:
As part of Novotech’s Clinical Data Programming unit, the Senior Clinical Data Programmer (SCDP) is responsible for database and application development work across multiple clinical data management projects, ensuring that they deliver in accordance with SOPs, programming best practices, and the timelines agreed within the Project Team. The SCDP acts as primary point of contact for project team members to address and resolve issues at technical and DB development level.
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 Practices.
Annotate CRFs according to CDISC standards (CDASH/SDTM) or sponsor-specific metadata requirem

📌 Senior Clinical Data Programmer (Bengaluru)
🏢 Novotech Global
📍 Bengaluru

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