Manager, Biomarker Operations

About the role

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.

Responsibilities

• 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 processes and procedures for standardized language, biomarker usage, and data reporting

Requirements

• Bachelor’s degree in a life science-based subject; advanced degree preferred
• Minimum of 5 years of clinical research experience which must include sponsor experience
• Direct experience with clinical sample management
• Familiarity with Excel is essential
• Solid understanding of GCP/ICH is required
• Strong communication skills and attention to detail
• Demonstrated ability to multitask