Description:

Despite the generic "Data Engineer" title, Tata Consultancy Services is hiring a specialized Electronic Data Capture (EDC) Systems Engineer to anchor clinical research database architectures. Operating inside the life-sciences BPS domain in alignment with pharmaceutical client frameworks (such as Takeda), you will lead the end-to-end technical construction, user-testing, and compliance governance of data collection interfaces for active clinical trials. The position acts as a technical Subject Matter Expert (SME)—accountable for writing automated logic checks, segregating multi-tenant security layers, mapping third-party lab integrations, and publishing operational Standard Operating Procedures (SOPs) to guarantee clinical data integrity through to database lock.

Key Technologies:

Electronic Data Capture (EDC) Systems (e.g., Medidata Rave, Oracle Clinical One, Veeva Vault CDMS), Electronic Case Report Forms (eCRFs), Interactive Response Technology (IRT), SQL/Database Engines

Requirements:

• Bachelor of Pharmacy (B.Pharm), Bachelor of Science (B.Sc.), Master of Science (M.Sc.), or a Master of Statistics degree.
• 3–10 years of professional hands-on technical validation and design experience operating inside Clinical Research data environments or clinical trial build processes.
• Advanced capability to translate clinical protocols into clear Electronic Case Report Form (eCRF) structural definitions, configuring modular data points, and running unit testing validation loops.
• High proficiency drafting edit check logic guidelines and programming/modifying data validation custom functions within the EDC runtime environment to screen for missing or anomalous data entries.
• Direct experience provisioning, checking, and managing distinct environmental staging layers (including User Acceptance Testing [UAT], testing sandboxes, and live Production instances).
• Competency handling system access layers, deploying granular permissions matrix configurations, and setting up secure blinded versus unblinded database access views for cross-functional study teams.
• Technical competency integrating the core EDC setup with adjacent specialized clinical systems—specifically connecting Interactive Response Technology (IRT) frameworks, pharmacovigilance safety software setups, and localized laboratory ingestion modules.
• Experience implementing mid-study, post-production structural updates without corrupting historic data blocks. Proven history handling full decommission loops, database-lock executions, and cloud instance archiving.
• Act as a technical bridge with software engine providers to resolve framework-level outages and performance anomalies.
• Strategic ability to establish technical delivery standards, construct data dictionary systems, and compile rigorous Standard Operating Procedures (SOPs) matching international data privacy regulations.