Clinical Data Ingestion Manager

This is a fully remote position, open to applicants in Poland.

📋 Description

• Assist in the integration of clinical data from EDC/CTMS and vendors into Veeva CDB, Elluminate, and JReview.

• Implement file/API-based data loads, which include mapping, transformations, referential integrity, and controlled reprocessing.

• Conduct and document quality checks for ingestion, validate outputs, reconcile results, and provide basic lineage/provenance tracking.

• Maintain reusable templates for ingestion, mappings, quality control rules, and operational runbooks.

• Oversee transfer monitoring, ensuring completeness and timeliness through checks, alert triage, escalation, scheduling, reruns, defect logging, and operational metric reporting.

• Prepare and validate exports and feeds for CDM, analytics, and programming teams.

• Collaborate with vendors and internal stakeholders to clarify specifications and acceptance criteria.

• Assist in troubleshooting and documenting solutions for repeatable processes.

• Adhere to controlled documentation and change management practices, ensuring validation, traceability, and audit-ready records are maintained.

⛳️ Requirements

• Bachelor’s degree (or equivalent) with over 5 years of experience in data ingestion/integration, ETL/ELT operations, or supporting clinical data pipelines.

• Familiarity with clinical data review systems such as Veeva CDB, Elluminate, and/or JReview (or similar platforms) is preferred.

• Understanding of transfer specifications/data contracts, refresh cadence, incremental versus full loads, controlled reprocessing, reconciliation, and basic lineage concepts.

• Capability to perform defined quality control/validation checks and document the outcomes.

• Practical experience with CSV, JSON, XML, and file/API integrations.

• Knowledge of secure transfer methods such as SFTP/MFT concepts is advantageous.

• Proficient in SQL and Python (preferred) or similar scripting languages.

• Ability to maintain and enhance reusable ingestion components with guidance.

• Experience in monitoring and operational processes including alerts, reruns, incident triage, and operational metrics.

• Familiarity with EDC, CTMS, and vendor feeds like labs, eCOA/ePRO, imaging, and safety data.

• Strong documentation skills and the ability to adhere to procedures in controlled/regulated environments.

• Excellent communication and collaboration skills with vendors and cross-functional teams.

• Detail-oriented and organized, capable of managing recurring operational tasks, identifying risks, and resolving issues efficiently.

• A commitment to integrity, honesty, and respect for others is essential.

🏝️ Benefits

• An equal opportunities employer.

• A culture that promotes inclusivity and sustainability in the workplace.

• AI-assisted recruitment support complemented by human decision-making.