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, BEHAVIORAL COMPETENCIES AND SKILLS:

Education:

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

Senior Manager Jobs

Takeda Pharmaceuticals

Senior Manager, Clinical Data Ingestion