Job Title: Clinical Data Ingestion Senior Manager
Location: Poland/Hungary/Mexico
Job Type: Full-Time
Job Overview:
Objective / Purpose: The Clinical Data Ingestion Senior Manager is responsible for ingesting, validating, and operationalizing clinical data feeds into clinical data review platforms (e.g., Veeva CDB, Elluminate, JReview) to enable efficient, high-quality clinical data review. This role focuses on strong ingestion principles, building and scaling reusable ingestion frameworks, and establishing monitoring and controls for vendor transfers and enterprise sources (e.g., EDC, CTMS) as well as managing downstream exports to enable analytics and programming teams.
Accountabilities:
- Ingest clinical data from EDC/CTMS and vendors (e.g., labs, eCOA, imaging, safety) into Veeva CDB/Elluminate/JReview per specifications and refresh cadence.
- Execute and support file/API loads, including mapping, transformations, referential integrity, and controlled reprocessing.
- Apply ingestion best practices: standardization, automated QC/validation, reconciliation, auditability/lineage, and incremental loads.
- Build and maintain a reusable ingestion framework and standards (templates, metadata-driven mappings, reusable QC rules, runbooks) to accelerate onboarding and improve consistency.
- Operate transfer monitoring and ingestion operations: expected vs received, timeliness/completeness checks, alerting/escalation, scheduling/re-runs, defect triage, and KPI/SLA tracking.
- Ensure datasets are review-ready and manage downstream exports to internal consumers with clear data contracts and refresh expectations.
- Partner with vendors and stakeholders to define/maintain transfer specs and acceptance criteria; provide SME troubleshooting and document fixes for repeatable operations.
- Follow controlled documentation and change practices for regulated clinical processes, maintaining validation/traceability evidence and audit-ready records as required.
Education & Competencies (Technical and Behavioral):
Education/Experience: BS/BA (or equivalent) plus 7+ years in data ingestion/integration, ETL/ELT operations, or clinical data pipeline support, ideally supporting clinical data review and recurring study/vendor transfers.
Technical Competencies :
- Preferred platform exposure: Experience ingesting data into Veeva CDB, Elluminate, and/or JReview (or comparable clinical data review systems).
- Clinical data ingestion principles: Strong understanding of end-to-end ingestion concepts including data contracts/specifications, refresh cadence, incremental vs full loads, controlled reprocessing, reconciliation, and traceable lineage.
- Data quality & Review readiness: Ability to design/execute automated QC/validation checks, completeness/timeliness verification, and reconciliation routines to ensure datasets are review-ready.
- Data formats & Interfaces: Hands-on experience with CSV, JSON, XML and file-based and/or API based integrations; familiarity with secure transfer patterns (e.g., SFTP/managed file transfer concepts). Querying & Scripting: Strong SQL skills; working proficiency in Python (preferred) or similar scripting to automate ingestion, QC, parsing, and operational tasks.
- Frameworks & reusability: Demonstrated ability to build or extend reusable ingestion components (metadata-driven mappings, templates, reusable QC rules, standard runbooks).
- Monitoring & Operations: Experience building/using monitoring for transfers and pipelines (e.g., expected vs received, timeliness/completeness checks, alerting, incident triage, reruns, KPI/SLA reporting).
Domain / Business Competencies
- Source system familiarity: Working knowledge of common clinical sources such as EDC, CTMS, and vendor domains (e.g., labs, eCOA/ePRO, imaging, safety) and how those feeds typically arrive and change over time.
- Downstream enablement: Understanding of downstream consumption needs (data review workflows, exports to CDM/analytics/programming) and ability to support stable, well-documented exports.
Compliance & Documentation
- Controlled processes mindset: Strong documentation discipline (specs, mappings, runbooks, issue logs) and comfort operating in controlled/regulated environments.
- Preferred: Exposure to GxP/CSV expectations, change control, and maintaining audit-ready operational evidence (as applicable to the organization/process).
Working Style
- Strong cross-functional communication and stakeholder management (vendors, CDM, data review, IT, analytics/programming).
- Detail-oriented, highly organized, Strong collaboration and communication; organized, self-directed, proactive problem-solver and able to manage recurring operational workloads while driving issues to closure and preventing recurrence.
Never miss an opportunity! Create an alert based on the job you applied for.