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12 часов назад

Regulatory and Start Up Specialist - Austria

Формат работы
remote (только Austria)
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
Austria
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 - Austria (Clinical Research): Perform country-level site activation and regulatory activities for clinical studies with an accent on document management, regulatory compliance, and study timeline coordination. Focus on preparing and quality-checking site documents, tracking regulatory and ethics approvals, and providing local expertise to project teams in Austria.

Location: Home based in Austria; Vienna, Austria. German language fluency required.

Company

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

What you will do

  • Serve as the single point of contact for investigative sites, Site Activation Managers, project management, and other departments.
  • Perform country-level start-up and site activation activities in line with regulations, SOPs, work instructions, and project requirements.
  • Prepare, review, distribute, and quality-check regulatory, contractual, ethics, informed consent, and investigator pack documents.
  • Maintain project information in clinical systems, databases, tracking tools, and internal records.
  • Track document approvals, execution, and site progress against project timelines.
  • Support planning, monitoring measures, contingency planning, and communication of site performance and deliverable status.

Requirements

  • Bachelor’s degree in life sciences or a related field and 3 years of clinical research or relevant experience, or an equivalent combination of education, training, and experience.
  • Fluency in German is required.
  • In-depth knowledge of clinical systems, procedures, and corporate standards.
  • Knowledge of GCP/ICH and applicable local and international regulatory guidelines.
  • Understanding of the regulated clinical trial environment and drug development process.
  • Ability to follow SOPs, maintain quality, and manage project timelines.

Culture & Benefits

  • Home-based work arrangement in Austria.
  • Work within a global provider of clinical research and healthcare intelligence services.
  • Responsibilities include collaboration with sponsors, investigative sites, and cross-functional project teams.

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