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7 дней назад

Regulatory & Start Up Specialist 1, cFSP - Global Support (Clinical Research)

Формат работы
remote (только Mexico)
Тип работы
fulltime
Грейд
junior
Английский
c1
Страна
Mexico
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 & Start Up Specialist 1, cFSP - Global Support (Clinical Research): Managing regulatory start-up and site activation activities for clinical studies in Mexico with an accent on document preparation, site coordination, and compliance with applicable regulations. Focus on tracking approvals, maintaining study systems, coordinating project timelines, and performing quality control across multiple priorities.

Location: Mexico City, Mexico; full home based role

Company

IQVIA 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 departments.
  • Manage study start-up and site activation activities in accordance with regulations, SOPs, and work instructions.
  • Prepare, review, distribute, and track regulatory, ethics, informed consent, investigator package, and contractual documents.
  • Maintain accurate study information in internal systems, databases, and tracking tools.
  • Monitor site performance metrics, project timelines, approvals, and document execution.
  • Provide local expertise, perform document quality control, and support contingency planning.

Requirements

  • Bachelor's degree in life sciences.
  • At least 1 year of clinical research and study start-up management experience.
  • Fluent English in written and oral communication.
  • Strong analytical, critical-thinking, interpersonal, communication, flexibility, and adaptability skills.
  • Demonstrated ability to manage multiple priorities and execute successfully in a fast-paced environment.

Culture & Benefits

  • Full home-based work arrangement.
  • Opportunity to support clinical research studies and the development of medical treatments.
  • Collaboration with global clinical research, project management, and healthcare intelligence teams.

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