Biomarker Operations Lead

Moderna Therapeutics

Cambridge (MA)

On-site

USD 109,200 - 174,600

Full time

14 days+

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Benefits offered by this job

Competitive healthcare

Well-being program

Family planning benefits

Generous paid time off

Discretionary equity/bonus potential

Job summary

Moderna is seeking a seasoned professional to independently support clinical biomarker sample management in trials. You will lead reviews of biomarker sections in protocols and consent forms, and drive central lab database specifications, sample handling, shipment, and reporting across the clinical lifecycle.

Strong knowledge of GCP/ICH, excellent communication, multitasking skills, and proficiency with Excel are essential.

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

Support implementation of clinical biomarker sample management plans and deliverables in Moderna trials.
Lead review of biomarker sections of protocols, lab manuals and consent forms.
Lead central lab database specification finalization, including sample kit development, storage, shipment, testing and reporting.
Track and manage clinical sample lifecycle from collection to long-term storage.
Monitor clinical sample quality issues and implement resolutions.
Ensure biosample usage complies with informed consent and GCP/ICH requirements.
Participate in clinical assay vendor oversight, attend meetings and manage sample shipments.
Promote process improvements for clinical sample lifecycle.
Lead development of processes for standardized language, biomarker usage, and data reporting.