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9 дней назад

Regulatory and Start Up Specialist - Belgium (Clinical Research)

Формат работы
remote (только Belgium)
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Belgium
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
Regulatory and Start Up Specialist - Belgium (Clinical Research): Coordinating regulatory submissions, site activation, essential trial documentation, and contract negotiations for clinical studies in Belgium with an accent on local regulatory compliance, investigative-site coordination, and study start-up delivery. Focus on managing approval timelines, reviewing site documentation, identifying activation risks, and supporting cross-functional teams through complex clinical trial requirements.

Location: Home-based within Belgium; Zaventem, Belgium

Company

hirify.global provides clinical research services, healthcare intelligence, and commercial insights to the life sciences and healthcare industries.

What you will do

  • Act as the primary contact for investigative sites, Site Activation Managers, project managers, sponsors, and internal stakeholders.
  • Coordinate country-specific site activation and regulatory activities for clinical studies.
  • Prepare, review, distribute, and track regulatory and essential study documentation, including ethics submissions, informed consent forms, investigator pack releases, and clinical trial agreements.
  • Support contract negotiation activities and manage related timelines.
  • Maintain accurate records, monitor milestones, identify risks, and develop mitigation plans.
  • Provide Belgian regulatory expertise, perform site-documentation quality reviews, and contribute to process improvement.

Requirements

  • Bachelor's degree in Life Sciences or a related scientific discipline.
  • Approximately 3.5–5 years of clinical research experience.
  • Strong experience in site activation, regulatory submissions, clinical trial start-up, and clinical trial agreement negotiations.
  • Solid understanding of Belgian and international clinical trial regulations.
  • Fluency in Dutch and/or French is essential.
  • Strong English communication skills required. Excellent planning, organization, problem-solving, stakeholder management, and communication abilities.

Culture & Benefits

  • Home-based flexibility within Belgium.
  • Opportunity to contribute to innovative clinical studies across multiple therapeutic areas and sponsors.
  • Global career development and advancement opportunities.
  • Collaborative and inclusive environment focused on growth and continuous learning.
  • Work supporting healthcare innovation and improved patient outcomes.

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