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4 дня назад

Clinical Trial Manager (Biotech)

131 000 - 181 000$
Формат работы
hybrid
Тип работы
fulltime
Грейд
middle
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 (Biotech): Planning, executing, overseeing, and delivering global clinical trials for allogeneic gamma delta T cell therapies with an accent on GCP/ICH compliance, site management, CRO oversight, and study milestones. Focus on leading study execution meetings, managing clinical trial documentation and metrics, performing co-monitoring visits, and addressing operational risks across cross-functional teams.

Location: Redwood City, California, United States; onsite at least three days per week, with Tuesday–Thursday mandatory

Salary: $131,000–$181,000 USD per year

Company

hirify.global is a clinical-stage biotechnology company developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer.

What you will do

  • Plan, execute, oversee, and deliver assigned global clinical trials in compliance with GCP, ICH guidelines, SOPs, timelines, and budgets.
  • Lead site and study management activities, including informed consent forms, site activation, monitoring reports, and study plan development.
  • Lead and present at Study Execution Team meetings and collaborate with cross-functional teams to resolve routine study issues.
  • Oversee CROs and vendors, track milestones, identify issues for escalation, and implement risk mitigation plans.
  • Perform co-monitoring visits during site qualification, initiation, routine monitoring, and close-out.
  • Maintain clinical trial master files, reports, listings, trackers, and site enrollment metrics.

Requirements

  • BS or higher degree in science, nursing, or an equivalent discipline.
  • At least four years of clinical research experience in biotechnology, pharmaceutical, or CRO settings.
  • Experience working with CROs and vendors and managing projects, contracts, vendors, and clinical research staff.
  • Strong working knowledge of FDA requirements, ICH guidelines, and GCPs governing clinical trials.
  • Experience with electronic data capture systems and Institutional Review Board preparations and submissions.
  • Ability to work onsite in Redwood City at least three days per week, with Tuesday–Thursday mandatory.

Nice to have

  • Knowledge of molecular diagnostics or laboratory skills.

Culture & Benefits

  • Collaborative, high-performing environment with an emphasis on in-person engagement.
  • Annual cash bonus, long-term equity incentives, Employee Stock Purchase Plan, and 401(k) with a 4.5% company match.
  • Medical, dental, vision, FSA, HSA, life, disability, legal, pet, and other insurance programs.
  • Paid time off, company holidays, paid winter break, sick time, and paid parental leave.
  • Onsite gym, parking with electric vehicle charging, Caltrain shuttle, subsidized lunches, and stocked breakrooms.

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