Manager, Data Quality Control, Clinical Biomarker Laboratory

The Role

The Clinical Biomarker Laboratory (CBL) at Moderna is seeking a Data QC Manager to perform hands‑on quality control review of laboratory data generated in support of clinical‑phase biomarker studies conducted within a GCP‑regulated laboratory environment. This role is primarily focused on the detailed review, verification, and reconciliation of laboratory data and documentation to support accurate, compliant data transfer and reporting.

This Data QC Manager serves as a key data integrity and compliance partner within the Clinical Biomarker Laboratory, ensuring that clinical laboratory data are accurate, traceable, inspection‑ready, and fit for regulatory submission. In this role, the Data QC Manager works closely with laboratory scientists, study teams, and data management partners to identify and resolve data discrepancies, ensuring that laboratory outputs are supported by reviewed and documented raw data.

The position reports to the Associate Director, Lab Compliance within the Clinical Biomarker Laboratory and is part of Moderna’s Clinical Assays and Supply Logistics (CASL) group. The role operates within the UK CASL Laboratory, maintaining appropriate alignment with UK laboratory leadership to support site awareness, inspection readiness, and data integrity expectations. This role requires on‑site presence five days per week at Moderna’s Harwell, UK laboratory.

• Adhere to analytical data quality and integrity standards in accordance with MHRA, ICH, and GCP requirements, applicable regulations, and established SOPs across clinical studies.
• Perform comprehensive quality control (QC) review of raw laboratory data, including paper records, electronic laboratory notebooks (ELN), instrument printouts, and electronic raw data files, to ensure data are complete, accurate, and fully traceable to the original source.
• Review calculations and data processing steps to confirm mathematical accuracy, appropriate use of formulas, correct application of dilution factors, acceptance criteria, and statistical methods.
• Confirm that all calculations are reproducible from raw data and properly documented, including both manual calculations and system-generated outputs.
• Review laboratory documentation for completeness, consistency, and compliance, including worksheets, analytical methods, SOPs, study plans, protocols, amendments, and associated source documents.
• Perform QC review of Laboratory Information Management System (LIMS) data entries, including sample metadata, test assignments, result entries, status changes, and approvals.
• Verify accuracy of data transcription into LIMS and ensure consistency between LIMS records, raw data, and source documentation.
• Compare laboratory data outputs against Data Transfer Specifications (DTS) to ensure correct data structure, formatting, units, controlled terminology, and completeness.
• Verify that transferred data accurately reflect approved and finalized laboratory results and comply with study‑specific and sponsor‑defined requirements.
• Review study plans, protocols, and reports to confirm alignment between planned activities, executed laboratory work, and reported results.
• Identify discrepancies, missing data, or inconsistencies during QC review; document findings in accordance with established procedures and issue QC observations as appropriate.
• Communicate data quality issues to study teams and scientific staff and support resolution through documented corrections, deviations, and/or CAPAs in accordance with SOPs.
• Ensure data integrity principles (ALCOA+) are applied throughout the data lifecycle, including data generation, review, correction, approval, transfer, and archival.
• Verify compliance of electronic records and electronic signatures with 21 CFR Part 11, EU Annex 11, and internal data governance requirements.
• Contribute to deviation investigations, root cause analyses, and CAPA development related to data quality and documentation issues.
• Assist with Excel workbook validation, including review of formulas, data integrity controls, versioning, and documentation.
• Participate in the review of protocols, analytical methods, reports, batch records,…