The Role
The Clinical Biomarker Laboratory (CBL) at Moderna is seeking a Data QC Specialist 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 focuses on the detailed review, verification, and reconciliation of laboratory data and documentation to support accurate, compliant data transfer and reporting.
The Data QC Specialist serves as a key data integrity and compliance partner within the Clinical Biomarker Laboratory, ensuring that laboratory data are accurate, traceable, inspection‑ready, and fit for regulatory submission. In this role, the Specialist will work 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 and is part of Moderna’s Clinical Assays and Supply Logistics (CASL) group, operating within the UK CASL Laboratory with on‑site presence five days per week at Moderna’s Harwell, UK laboratory.
Here’s What You’ll Do
- Adhere to analytical data quality and integrity standards in accordance with MHRA, ICH, GCP requirements, applicable regulations, and established SOPs across clinical studies.
- Perform comprehensive 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 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, and GCP source documents, actively managing data and documentation using systems such as Excel, LabVantage LIMS, and Veeva in support of clinical‑phase studies.
- Support internal and external audits by responding to data‑related inquiries and providing documented evidence of data traceability and compliance.
- Collaborate with Quality Assurance and cross‑functional teams to support the ongoing evolution of the Quality Management System (QMS) and implementation of risk‑based quality management approaches.
- Coordinate with internal and external stakeholders to identify and implement solutions to improve clinical laboratory data quality and analysis processes.
- Operate with a consistently high level of efficiency and attention to detail, producing accurate, high‑quality work in a fast‑paced, regulated environment.
Here’s What You’ll Need (Basic Qualifications)
- Bachelor’s / Master’s / PhD degree in Biological Sciences or related scientific discipline, with strong background in quality data analytics.
- 3+ years of relevant clinical laboratory experience in the pharmaceutical industry or CROs including data analysis and QC review of data.
- Demonstrated experience performing independent QC review of complex analytical datasets, including reconciliation between raw data, processed results, and reported outputs.
- Knowledge in various lab‑based techniques such as LC/MS, immunoassays, cell‑based assays, cytometry, and other platforms for the investigation of biomarkers in clinical phase studies.
- Preferred knowledge of Bioanalytical Method Validation for Industry.
- Knowledge of data management tools, electronic systems, and data integrity requirements.
- Previous experience working in GxP regulated laboratory is highly preferred.
- Hands‑on experience and knowledge of quality systems and regulatory requirements (Medicines for Human Use (Clinical Trials) Regulations 2004‑SI 2004 No. 1031 as amended, the ICH Guideline for Good Clinical Practice E6(R3), and the Good Clinical Laboratory Practice guidelines: EMA/INS/GCP/532137/2010 and WHO, 2009).
- Proficiency with Microsoft Office Suite (Outlook, Excel, Word, etc.). Proficiency with statistical analysis methodologies is a plus.
- Strong attention to detail, sound judgment, organizational ability, a team player attitude, and effective written and verbal communication skills.
- Ability to work effectively in a team environment while managing multiple concurrent projects and priorities.
- Ability to work independently while taking direction and adapting to changing study and business needs.
- This position is site‑based, requiring you to be at Moderna’s site full‑time. Remote work is not eligible.
- As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre‑employment check.
Pay & Benefits
- Best‑in‑class healthcare, plus voluntary benefit programs to support your unique needs.
- A holistic approach to well‑being with access to fitness, mindfulness, and mental health support.
- Family building benefits, including fertility, adoption, and surrogacy support.
- Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown.
- Savings and investments to help you plan for the future.
- Location‑specific perks and extras.
Moderna is a smoke‑free, alcohol‑free, and drug‑free work environment.
Moderna is committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com.
