Clinical Data Ingestion Manager

An exciting opportunity to join Veramed's Data Management Business Unit! Are you passionate about clinical data, data integration, and building reliable pipelines that drive better decisions in drug development? We're looking for a Clinical Data Ingestion Manager to play a key role in ensuring high-quality clinical data flows seamlessly from multiple sources into cutting-edge review platforms.

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:
• 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 environment 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