Clinical Data Ingestion Manager

Veramed; United States; A distancia; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Veramed is seeking a Clinical Data Ingestion Manager to oversee ingestion of clinical data from EDC/CTMS sources into review platforms such as Veeva CDB, Elluminate, and JReview. You will design and execute ingestion processes, monitor data quality, and maintain reusable templates and runbooks within a GxP framework.

You will collaborate with vendors and internal teams to ensure timely, accurate, and audit-ready datasets for study teams, supporting downstream exports and data contracts across

Formación

• BS/BA (or equivalent) and 5+ years in data ingestion/integration, ETL/ELT operations, or clinical data pipeline support.
• Exposure to clinical data review systems such as Veeva CDB, Elluminate, and/or JReview (or similar platforms).
• Understanding of transfer specs, refresh cadence, incremental vs. full loads, and basic data lineage.

Responsabilidades

• Ingest clinical data from EDC/CTMS and vendors into Veeva CDB/Elluminate/JReview per approved specs and cadence.
• Execute and support file/API loads with mapping, transformations, and referential integrity; perform controlled reprocessing.
• Conduct ingestion QC checks (completeness, timeliness, reconciliation) and document results for review-ready datasets.
• Maintain reusable ingestion components (templates, mappings, QC rules, runbooks) and propose improvements.
• Support transfer monitoring and escalation, scheduling, reruns, and operational metric reporting.
• Prepare and validate outputs for downstream consumers against data contracts and refresh expectations.
• Collaborate with vendors and internal teams to clarify transfer specs and document fixes for repeatable operations.
• Follow regulated documentation practices and maintain audit-ready records in controlled environments.

Educación

BS/BA (or equivalent)

Herramientas

Veeva CDB

Elluminate

JReview

CSV

JSON

XML

SQL

Python

Descripción del empleo

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.

In this role, you'll be at the heart of clinical data operations, managing the ingestion, quality control, monitoring, and delivery of data from EDCs, CTMS platforms, and external vendors into systems such as Veeva CDB, Elluminate, and JReview. Your work will ensure study teams have timely, accurate, and review-ready data to support critical development milestones.

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, elevate risks early, and drive issues to closure with support.

Veramed is a B Corp accredited company which means that we use the power of business to build a more inclusive and sustainable economy meeting the highest verified standards of social and environmental performance, transparency, and accountability.

As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. All qualified applicants will receive equal consideration for employment.