Manager, Biomarker Operations

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.

Responsibilities

Independently support 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; 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; Only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position

Nice to have

Advanced degree preferred

Benefits

Competitive healthcare; voluntary benefit programs to support your unique needs; holistic approach to well-being with access to fitness, mindfulness, and mental health support; family planning benefits including fertility, adoption, and surrogacy support; generous paid time off including vacation, 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; annual discretionary bonus, other incentive compensation, or equity award