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8 дней назад

Manager, Biomarker Operations

109 200 - 174 600$
Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Manager, Biomarker Operations (Clinical Research/Biotech): Supporting biomarker and clinical teams by managing biosample plans, clinical sample lifecycles, laboratory databases, and vendor activities across clinical trials with an accent on sample quality, compliance, and standardized processes. Focus on reviewing clinical trial documentation, resolving sample issues, ensuring GCP/ICH-compliant biosample usage, and coordinating assay laboratories and CROs.

Location: Cambridge, Massachusetts, United States; hybrid 70/30 work model with significant in-office collaboration. Only U.S. persons are eligible due to export control requirements.

Salary: $109,200–$174,600 per year, with potential eligibility for a discretionary annual bonus, other incentive compensation, or equity awards.

Company

hirify.global develops mRNA-based medicines and vaccines using its mRNA science, delivery technology, and manufacturing platform.

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 clinical sample lifecycles from collection through long-term storage and resolve sample quality issues.
  • Support compliant biosample usage according to informed consent and GCP/ICH requirements.
  • Coordinate assay vendor oversight, sample issue resolution, shipments, process improvements, and standardized biomarker reporting procedures.

Requirements

  • Bachelor’s degree in a life science-related 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 and direct mentorship.
  • Healthcare coverage and voluntary benefit programs.
  • Fitness, mindfulness, and mental health support.
  • Family planning benefits, including fertility, adoption, and surrogacy support.
  • Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
  • Savings and investment programs plus location-specific benefits.

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