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9 часов назад

Senior Clinical Trial Manager, Clinical Operations (Oncology)

152 000 - 190 000$
Формат работы
remote (только USA)/onsite
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, Clinical Operations (Oncology) (Early-Phase Oncology Trials): Leading end-to-end operational execution of complex oncology studies from start-up through close-out with an accent on CRO oversight, enrollment strategy, regulatory compliance, and inspection readiness. Focus on managing global multi-site trials, mitigating operational risks, coordinating cross-functional teams, and maintaining timeline, budget, and data quality performance.

Location: Remote in the United States or onsite in San Diego, California; up to 10% travel required.

Salary: $152,000–$190,000 per year

Company

hirify.global is a clinical-stage life-science and technology company developing medicines through an AI-driven drug discovery and development platform.

What you will do

  • Lead complex early-phase oncology clinical trials from start-up through close-out, ensuring on-time, on-budget, compliant delivery.
  • Coordinate cross-functional study teams across Clinical Development, Regulatory, Biometrics, Data Management, Medical, and external partners.
  • Develop enrollment, site management, monitoring, training, and study execution strategies.
  • Oversee CRO and vendor performance, including KPIs, monitoring quality, document review, approval, and vendor selection support.
  • Manage protocols, informed consent forms, project plans, budgets, study materials, and operational tools.
  • Identify and mitigate operational risks, support data review and query resolution, and mentor junior clinical operations staff.

Requirements

  • Bachelor’s degree in life sciences or a related field and 7+ years of progressive clinical trial management experience in biotech, pharmaceutical, or CRO environments.
  • Experience managing global, multi-site clinical trials from start-up through close-out and overseeing CRO partners.
  • Required oncology clinical trial experience; solid tumor and early-phase Phase I/Ib or II experience preferred.
  • In-depth knowledge of ICH-GCP, FDA/EMA regulations, global regulatory requirements, quality standards, and inspection readiness.
  • Proficiency with CTMS, eTMF, IRT, EDC, and safety database systems.
  • Ability to work in a collaborative, fast-paced, growth-stage biotech environment with evolving priorities and high accountability.

Nice to have

  • Experience with solid tumor studies and early-phase Phase I/Ib or II trials.
  • Experience mentoring clinical operations staff or managing through dotted-line reporting relationships.

Culture & Benefits

  • Collaborative, inclusive environment bringing together AI experts and experienced drug developers.
  • Company-paid healthcare and flexible spending accounts.
  • 401(k) matching and voluntary life insurance.
  • Uncapped vacation.
  • San Diego facility with an onsite gym and dining.

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