Clinical Data Enablement Senior Manager

Greetings !

We are hiring for TCS Client !

Job Description: Clinical Data Enablement Senior Manager

Job Location : Pan India (Remote)

Experience: 7+ Years

Role Overview

The Clinical Data Enablement Senior Manager is responsible for managing, operating, and continuously improving end-to-end clinical data pipelines across cloud-based data lakes and data warehouse environments. The role focuses on building scalable ETL/ELT solutions, integrating data from multiple sources, ensuring data quality and operational reliability, and delivering compliant clinical data products to downstream stakeholders.

The position requires strong expertise in data engineering, cloud platforms, pipeline automation, operational monitoring, and GxP-regulated environments, along with the ability to collaborate with cross-functional teams and external vendors.

Key Responsibilities

• Manage end-to-end clinical data pipelines across data lakes and data warehouses, including development, monitoring, maintenance, troubleshooting, and performance optimization.
• Build and scale cloud-based ETL/ELT pipelines using AWS and/or Azure for data ingestion, transformation, orchestration, and delivery.
• Implement monitoring, alerting, incident management, root-cause analysis (RCA), and corrective and preventive actions (CAPA).
• Automate pipeline scheduling, metadata-driven processing, data integration, reconciliation, and automated data quality checks.
• Collaborate with vendors and cross-functional teams to define data transfer specifications, acceptance criteria, integration patterns, and error-handling mechanisms.
• Serve as a subject matter expert in structured and unstructured data integration, driving continuous improvements based on business requirements and stakeholder feedback.
• Partner with Statistical Programming, SDTM, Clinical Data Programming, and Analytics teams to deliver fit-for-purpose clinical datasets and interfaces.
• Establish and manage Service Level Agreements (SLAs) and Operational Level Agreements (OLAs), ensuring timely and accurate data delivery.
• Develop and maintain operational dashboards, KPIs, and metrics to track pipeline performance, delivery timeliness, success rates, and defects.
• Design and implement GxP-compliant clinical data engineering solutions with appropriate documentation, traceability, and audit-ready evidence.
• Ensure data integrity through ALCOA+ principles, change control, incident and deviation documentation, periodic reviews, and inspection readiness.
• Collaborate with Quality, Compliance, and IT teams to implement access controls, audit trails, logging, and operational governance.
• Follow SDLC best practices, maintain technical documentation, and support continuous improvement initiatives.

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