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3 дня назад

Clinical Trial Manager (Contract)

72 - 82$
Формат работы
remote (только USA)
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
Clinical Trial Manager (Contract) (Biotechnology): Managing day-to-day operations of Phase 1–3 clinical trials, including startup, conduct, closeout, CRO oversight, documentation, budgets, and site activities with an accent on retina trials, GCP compliance, and cross-functional execution. Focus on coordinating complex study deliverables, maintaining audit-ready trial documentation, managing risks and protocol deviations, and controlling timelines, quality, and costs.

Location: Remote within the United States; company location in Emeryville, California. Travel to clinical sites, conferences, and industry meetings as needed; approximately 5% travel.

Salary: $72.00–$82.00 per hour.

Company

hirify.global is a biotechnology company developing targeted AAV gene therapies for rare and large-market diseases through its Therapeutic Vector Evolution platform.

What you will do

  • Manage day-to-day operations for one or more Phase 1–3 clinical trials from startup through closeout.
  • Oversee CROs, service providers, consultants, monitors, and investigational sites while leading cross-functional study execution.
  • Track study milestones, timelines, budgets, quality metrics, protocol deviations, clinical supplies, and financial performance.
  • Prepare and review protocols, informed consents, investigator brochures, monitoring plans, case report forms, statistical analysis plans, and clinical study reports.
  • Maintain the Trial Master File and audit-ready clinical documentation, and coordinate resolution of audit findings and site issues.
  • Support site selection, feasibility, training, contracting, monitoring visits, data review, and process improvement initiatives.

Requirements

  • B.A. or B.S. degree in Science.
  • 6+ years of clinical research experience in biotechnology or a similar industry.
  • At least 2 years of direct experience supporting retina clinical trials.
  • Knowledge of GCP, ICH guidelines, regulatory requirements, clinical trial methodology, and clinical study management.
  • Experience with trial planning, site monitoring, risk mitigation, site selection, budgets, clinical supplies, and protocol execution.
  • Strong communication, organization, negotiation, conflict resolution, prioritization, problem-solving, collaboration, and Microsoft Office skills; working knowledge of MS Project.

Nice to have

  • Global APAC clinical trial experience.
  • Experience developing therapeutic area knowledge through training and industry conferences.

Culture & Benefits

  • Work in a collaborative, results-driven biotechnology environment focused on gene therapy innovation.
  • Opportunities for career development and challenging clinical operations work.
  • Company values include patient focus, calculated risk-taking, innovation, collaboration, and disciplined execution.
  • Equal employment opportunity is provided in accordance with applicable laws.

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