(Fixed Term) Data Quality Control Specialist. Clinical Biomarker 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.· Verify that transferred data accurately reflect approved and finalized laboratory results and comply with study-specific and sponsor-defined requirements.· Verify compliance of electronic records and electronic signatures with 21 CFR Part 11, EU Annex 11, and internal data governance requirements.**Here’s What You’ll Need (Basic Qualifications)** · 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.· As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check.* 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#J-18808-Ljbffr…