(Fixed Term) Data Quality Control Specialist. Clinical Biomarker Laboratory

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 is primarily focused 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 clinical laboratory data are accurate traceable inspection-ready and fit for regulatory this role The Data QC 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. This role is execution-focused and supports inspection readiness through consistent high-quality data review practices.

This position reports to the Associate Director Lab Compliance within the Clinical Biomarker Laboratory and is part of Modernas 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 Modernas Harwell UK laboratory.

Heres What Youll Do

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 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.

Heres What Youll Need (Basic Qualifications)

Bachelors / Masters/ 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.

Knowledge of Bioanalytical Method Validation for Industry is preferred.

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 Modernas site full-time. This position is not eligible for remote work.

As part of Modernas commitment to workplace safety this role may require an enhanced pre-employment check.

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and well-being resources are designed to support youat work at home and everywhere in between.

• 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

• Savingsandinvestments to help you plan for the future

• Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

Since our founding in 2010 we have aspired to build the leading mRNA technology platform theinfrastructure to reimagine how medicines are created and delivered and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission values and mindsets every day our peopleare the driving force behind our scientific progress and our we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.

As we build our company we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

Moderna is a smoke-free alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!

Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a persons 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.

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.

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 .

-