23 часа назад
Manager, Biomarker Operations
109 200 - 174 600$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager, Biomarker Operations (Clinical Research): Managing biomarker sample plans and clinical sample lifecycles across Moderna clinical trials with an accent on protocol review, central laboratory coordination, sample quality, and regulatory compliance. Focus on developing standardized biomarker processes, overseeing assay vendors and CROs, and resolving complex biosample management issues under GCP/ICH requirements.
Location: Cambridge, Massachusetts, United States; 70% in-office and 30% remote. Only U.S. persons are eligible due to U.S. export control requirements.
Salary: $109,200–$174,600 per year, with potential eligibility for an annual discretionary bonus, other incentive compensation, or equity.
Company
develops mRNA technology and medicines through clinical research, scientific innovation, and biopharmaceutical development.
What you will do
- Implement biomarker sample management plans and deliverables for clinical trials.
- Review biomarker sections of clinical protocols, laboratory manuals, and consent forms.
- Finalize central laboratory database specifications and coordinate sample kit development, storage, shipment, testing, and reporting.
- Track the clinical sample lifecycle from collection through long-term storage and resolve sample quality issues.
- Support compliant biosample use under informed consent and GCP/ICH requirements.
- Oversee clinical assay vendors and CRO activities while developing standardized biomarker processes and reporting procedures.
Requirements
- Bachelor’s degree in a life science subject; an advanced degree is preferred.
- At least 5 years of clinical research experience, including sponsor-side experience.
- Direct experience with clinical sample management.
- Familiarity with Excel and a solid understanding of GCP/ICH requirements.
- Strong communication, attention to detail, and multitasking skills.
- Eligibility as a U.S. person is required; non-U.S. persons cannot be sponsored for an export control license.
Culture & Benefits
- 70/30 in-office work model emphasizing collaboration, innovation, teamwork, and mentorship.
- Healthcare and voluntary benefit programs.
- Fitness, mindfulness, and mental health resources.
- Family planning support, including fertility, adoption, and surrogacy benefits.
- Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
- Savings and investment programs plus location-specific perks.
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