Biomarker Operations Lead: Clinical Trials

BioSpace; Cambridge (MA); 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

Equity opportunities

Job summary

Moderna seeks a Biomarker Operations Manager to support biomarker and clinical teams across its clinical trials and with external biorepositories, assay laboratories and CROs. The role collaborates across therapeutic areas to ensure compliant biosample plans and management.

Responsibilities include implementing biomarker sample management plans, reviewing biomarker sections of protocols, and overseeing lab databases and sample lifecycle from collection to storage, while ensuring GCP/ICH

Qualifications

• Bachelor’s degree in a life science-based subject; advanced degree preferred.
• Minimum of 5 years of clinical research experience including 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

Strong communication skills

Attention to detail

Multitasking

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

Excel

Job description

Moderna seeks a Biomarker Operations Manager to support biomarker and clinical teams across its clinical trials and with external biorepositories, assay laboratories and CROs. The role collaborates across therapeutic areas to ensure compliant biosample plans and management.

Responsibilities include implementing biomarker sample management plans, reviewing biomarker sections of protocols, and overseeing lab databases and sample lifecycle from collection to storage, while ensuring GCP/ICH