Biomarker Operations Lead - Clinical Trials & Biosamples

RXinsider LTD.

Cambridge, Northern (MA, KY)

Hybrid

USD 109,000 - 175,000

Full time

9 days ago

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Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Paid time off

Job summary

Moderna is seeking a Biomarker Operations Manager to support biomarker and clinical teams across its clinical trials and external collaborations. The role ensures compliant biosample plans, management, and reporting for trials conducted by Moderna.

You will lead cross-functional efforts in protocol review, central lab specifications, and process improvements for the biomarker lifecycle, with an emphasis on GCP/ICH compliance and clear data reporting.

Qualifications

Bachelor's degree in life sciences or related field.
Minimum 5 years clinical research experience including sponsor interactions.
Direct experience with clinical sample management.
Familiarity with Excel is essential.
Solid understanding of GCP/ICH requirements.
Strong communication skills and attention to detail.

Responsibilities

Implement clinical biomarker sample management plans across Moderna trials.
Lead review of biomarker sections in protocols, lab manuals and consent forms.
Finalize central lab database specs including sample kit development, storage, shipping, testing and reporting.
Track and manage clinical sample lifecycle from collection to long-term storage.
Monitor sample quality issues and drive resolutions.
Ensure biosample use complies with informed consent and GCP/ICH.