About this role
Moderna, Inc. Biomarker Operations Manager
Moderna is seeking a Biomarker Operations Manager to support biomarker and clinical teams across its clinical trials as well as with external biorepositories, assay laboratories and CROs. This position will work collaboratively across all therapeutic area teams to ensure implementation, compliance and support of biosample plans and management for clinical trials conducted by Moderna.
Here’s What You’ll Do Independently support for implementation of clinical biomarker sample management plans and deliverables in Moderna clinical trials Lead the review of biomarker sections of clinical protocols, lab manuals and consent forms Lead central lab database specification finalization, including clinical sample kit development, sample storage, sample shipment, sample testing and reporting Track and manage clinical sample lifecycle processes from sample collection to long term storage Monitor clinical sample quality issues and implement issue resolutions Support clinical teams to ensure biosample usage is compliant with informed consent and GCP/ICH requirements Participate in clinical assay vendor oversight, by attending meetings, addressing sample issues, and requesting sample shipments Promote process improvements for clinical sample lifecycle Lead the development of process