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3 дня назад

Senior Clinical Trial Manager (Biotech)

150 000 - 175 000$
Формат работы
remote (только USA)/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
Senior Clinical Trial Manager (Biotech): Managing and overseeing clinical studies for an integrated cancer immunotherapy platform with an accent on study planning, CRO oversight, site activation, enrollment, and trial closeout. Focus on ensuring ICH/GCP compliance, managing investigational products and Trial Master Files, and coordinating complex cross-functional clinical operations.

Location: Remote within the United States; ideally based in Seattle, Washington, with onsite work at least 2 days per week. Approximately 20% travel may be required.

Salary: $150,000–$175,000 annual salary for the Senior Manager level.

Company

hirify.global is a biotechnology company developing off-the-shelf cancer therapies through an integrated immunotherapy platform.

What you will do

  • Manage the operational execution and oversight of clinical studies within quality, timeline, and budget requirements.
  • Develop study timelines, deliverables, risk mitigation strategies, study plans, monitoring guidelines, and site materials.
  • Lead CRO and vendor selection, performance management, study team meetings, and site monitoring activities.
  • Track site start-up, activation, subject enrollment, data collection, and trial closeout.
  • Manage site budgets and payments, investigator relationships, investigational product accountability, and product shipments.
  • Oversee the Trial Master File and collaborate with Clinical Operations, Biometrics, Data Management, Regulatory Affairs, Pharmacovigilance, and Clinical Quality Assurance.

Requirements

  • Bachelor’s degree or equivalent in Life Sciences.
  • At least 8 years of clinical operations experience in the pharmaceutical industry, including 3+ years managing industry-sponsored clinical trials as a sponsor employee.
  • Significant knowledge of GCP/ICH guidelines and the clinical development process.
  • Experience independently planning and conducting clinical studies, managing CROs and vendors, and assessing performance.
  • Experience leading, managing, or mentoring clinical operations staff and cross-functional teams.
  • Ability to work onsite 2 days per week at the Seattle office or work remotely from within the United States.

Nice to have

  • Experience supporting Phase 1 and Phase 2 clinical trials.
  • Oncology experience.

Culture & Benefits

  • Medical, dental, and vision insurance plans.
  • 401(k) plan with a 100% match on the first 4% of employee deferral.
  • Paid time off and commuter benefits.
  • Cell phone stipend.
  • Fast-paced, entrepreneurial environment focused on cancer treatment innovation.

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