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5 часов назад

Project Manager, FSA (Clinical Research)

Формат работы
remote (только Japan)/onsite
Тип работы
fulltime
Английский
b2
Страна
Japan
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
Project Manager, FSA (Clinical Research): Planning and managing feasibility and site activation activities for clinical studies with an accent on study start-up planning, regulatory submissions, essential document collection, and milestone control. Focus on coordinating cross-functional stakeholders, identifying activation risks, and delivering site start-up activities within quality and timeline expectations.

Location: Osaka or Tokyo, Japan; remote or office-based work available

Company

hirify.global is a healthcare intelligence and clinical research organization supporting clinical development.

What you will do

  • Plan and manage feasibility and site activation project plans, timelines, budgets, resources, and deliverables.
  • Coordinate feasibility assessments, country and site recommendations, and site activation strategies with functional experts.
  • Oversee essential document collection, ethics and regulatory submissions, contract-related activities, and activation milestones.
  • Track progress against timelines and KPIs, identify risks, and implement mitigation plans.
  • Act as the primary FSA contact for internal teams, sponsors, and customers on study start-up matters.
  • Support audits and inspections as an FSA representative and contribute to process improvements.

Requirements

  • Bachelor’s degree in life sciences, healthcare, business, or a related field, or equivalent experience.
  • Experience leading or supporting clinical trial start-up activities, including feasibility, site activation, budgets, resources, or Site Activation Plans.
  • Experience as a Project Manager or Clinical Trial Manager is required.
  • Understanding of regulatory, ethics, and contractual requirements affecting study start-up.
  • Strong project planning, organizational, communication, and stakeholder management skills.
  • Business-level English is required. Willingness to travel approximately 10% as needed.

Culture & Benefits

  • Inclusive and accessible work environment focused on diversity, belonging, and equal opportunity.
  • Annual leave and country-specific benefits.
  • Health insurance options for employees and families.
  • Retirement planning, life assurance, and employee assistance support.
  • Optional benefits may include childcare vouchers, gym memberships, travel subsidies, and health assessments.

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