(Fixed Term) Manager, Data Quality Control, Clinical Biomarker Laboratory at Moderna

Oxford, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

04 Oct, 26

Salary

0.0

Posted On

06 Jul, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Data Quality Control, GCP Compliance, LIMS, Bioanalytical Method Validation, Data Integrity, ALCOA+, QC Review, Clinical Biomarker Studies, Statistical Analysis, Regulatory Compliance, Root Cause Analysis, CAPA, Veeva, LabVantage, Microsoft Excel, Analytical Data Analytics

Industry

Biotechnology Research

Description

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. The 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 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 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. Here’s What You’ll 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. • Participate and drive continuous improvement within Data QC and Compliance teams • Establish and revise procedures to support data QC activities. • Work both independently and collaboratively with the teams. 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. • 10+ 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. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Competitive 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 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, the infrastructure 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 people are the driving force behind our scientific progress and our culture. Together, 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 modernatx.com/careers 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 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. We’re 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 leavesandaccommodations@modernatx.com. - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

Responsibilities

Perform hands-on quality control review of laboratory data and documentation to ensure accuracy, traceability, and compliance for clinical-phase biomarker studies. Collaborate with study teams to resolve data discrepancies and maintain inspection readiness in a GCP-regulated environment.