Biomarker Operations Lead

RXinsider LTD.; Cambridge, Northern (MA, KY); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being resources

Family planning benefits

Generous paid time off

Savings & investments

Location-specific perks

Job summary

Moderna is seeking a Biomarker Operations Manager to support biomarker and clinical teams across its clinical trials, as well as external biorepositories, assay laboratories, and CROs. You will collaborate across therapeutic areas to ensure implementation, compliance and support of biosample plans and management for Moderna trials.

Required 5+ years in clinical research with sponsor experience, direct biomarker sample management, strong Excel skills, and a solid understanding of GCP/ICH.

Qualifications

• 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.

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

Skills

Excel

GCP/ICH

Communication skills

Attention to detail

Multitasking

Education

Bachelor’s degree in life science

Advanced degree preferred

Job description

Moderna is seeking a Biomarker Operations Manager to support biomarker and clinical teams across its clinical trials, as well as external biorepositories, assay laboratories, and CROs. You will collaborate across therapeutic areas to ensure implementation, compliance and support of biosample plans and management for Moderna trials.

Required 5+ years in clinical research with sponsor experience, direct biomarker sample management, strong Excel skills, and a solid understanding of GCP/ICH.