Objective / Purpose

The Clinical Data Ingestion Manager is responsible to support reliable, timely, and traceable ingestion of clinical data from EDC/CTMS and vendors into clinical data review platforms (e.g., Veeva CDB, Elluminate, JReview) by executing defined ingestion processes, performing QC/reconciliation and transfer monitoring, maintaining reusable templates/runbooks, and producing accurate documentation to enable review-ready datasets and downstream exports in a controlled (GxP) environment.

Accountabilities

- Support ingestion of clinical data from EDC/CTMS and vendors (e.g., labs, eCOA, imaging, safety) into Veeva CDB/Elluminate/JReview by executing loads per approved specifications and refresh cadence.
- Execute and support file/API-based loads (mapping, transformations, referential integrity) and perform controlled reprocessing under established procedures.
- Perform and document ingestion quality checks (standardization, automated QC/validation outputs, reconciliation results, and basic lineage/provenance) to help ensure review ready datasets.
- Contribute to reusable ingestion frameworks and standards by maintaining templates/mappings, QC rules, and runbooks; propose improvements to reduce manual effort.
- Support transfer monitoring and ingestion operations: expected vs received, timeliness/completeness checks, alert triage/escalation, scheduling/re-runs, defect logging, and operational metric reporting.
- Assist with downstream exports/feeds to internal consumers (CDM, analytics, programming) by preparing and validating outputs against defined data contracts and refresh expectations.
- Partner with vendors and internal stakeholders to clarify transfer specs and acceptance criteria; support troubleshooting and ensure fixes are documented for repeatable operations.
- Follow controlled documentation and change practices for regulated clinical processes, maintaining required validation/traceability evidence and audit-ready records as assigned.





Education & Competencies (Technical and Behavioral):
- Education/Experience: BS/BA (or equivalent) plus 5+ years in data ingestion/integration, ETL/ELT operations, or clinical data pipeline support, ideally supporting clinical data review and recurring study/vendor transfers.
- Platform exposure (preferred): Exposure in clinical data review systems such as Veeva CDB, Elluminate, and/or JReview (or comparable platforms).
- Clinical data ingestion fundamentals: Understanding of ingestion basics such as transfer specs/data contracts, refresh cadence, incremental vs. full loads, controlled reprocessing, reconciliation, and basic lineage.
- Data quality & Review readiness: Ability to execute defined QC/validation checks (completeness/timeliness, reconciliation) and document results to support review ready datasets.
- Data formats & Interfaces: Hands-on with CSV, JSON, XML and file/API-based integrations; familiarity with secure transfers (e.g., SFTP/MFT concepts) is a plus.
- Querying & Scripting: Working knowledge of SQL and Python (preferred) or similar scripting to support ingestion automation, parsing, and operational tasks.
- Frameworks & Reusability: Ability to maintain and extend existing reusable ingestion components (templates, mappings, QC rules, runbooks) under guidance.
- Monitoring & Operations: Experience using monitoring/operational processes (e.g., expected vs received, alerts, reruns, incident triage) and reporting basic operational metrics.
- Source system familiarity: Familiarity with common clinical sources such as EDC, CTMS, and vendor feeds (labs, eCOA/ePRO, imaging, safety) and how data arrives/changes over time.
- Controlled setting readiness: Strong documentation habits (specs, mappings, runbooks, issue logs) and ability to follow defined procedures in controlled/regulated settings.
- Clear communicator and collaborative team member; comfortable working with vendors and cross-functional partners with guidance.
- Detail-oriented and organized; able to manage recurring operational tasks, escalate risks early, and drive issues to closure with support

📌 Clinical Data Ingestion Manager (India)
🏢 Veramed
📍 India