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13 дней назад

Country Activation and Submission Representative (Clinical Research)

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
France
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
Country Activation and Submission Representative (Clinical Research): Managing site activation and regulatory submission activities for clinical trials in France with an accent on document quality, regulatory compliance, and project timelines. Focus on coordinating investigative sites, tracking ethics and regulatory approvals, maintaining clinical systems, and resolving timeline risks.

Location: Paris, France

Company

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

What you will do

  • Act as the single point of contact for investigative sites, Site Activation Managers, project management, and other internal departments.
  • Perform country-level start-up and site activation activities in accordance with applicable regulations, SOPs, work instructions, and project requirements.
  • Prepare, review, distribute, and track regulatory, ethics, contractual, informed consent, and Investigator Pack documents.
  • Maintain accurate project information in internal systems, databases, and tracking tools.
  • Review site performance metrics, project plans, timelines, and monitoring measures, implementing contingency plans when needed.
  • Provide local regulatory expertise and perform quality control of documents submitted by sites.

Requirements

  • Bachelor’s degree in life sciences or a related field.
  • At least 3 years of clinical research or other relevant experience.
  • In-depth knowledge of clinical systems, procedures, and corporate standards.
  • Knowledge of GCP/ICH, local regulatory requirements, SOPs, and regulated clinical trial environments.
  • Understanding of the drug development process and ability to ensure document accuracy, quality, and timely completion.

Culture & Benefits

  • Full-time employment within a global clinical research and healthcare intelligence organization.
  • Work aligned with applicable local and international regulations, quality standards, and project requirements.
  • Collaboration with investigative sites, sponsors, project teams, and regulatory stakeholders.

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