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8 дней назад

Project Specialist (Clinical Research)

Формат работы
remote (только Argentina)
Тип работы
fulltime
Английский
b2
Страна
Argentina
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 Specialist (Clinical Research): Coordinating cross-functional clinical research project delivery, communications, documentation, vendor budgets, and audit readiness with an accent on project administration, regulatory knowledge, and clinical operations. Focus on managing study systems, tracking invoices and supplies, maintaining action logs, and supporting compliance with ICH/GCP, FDA, EU, and ISO 14155 requirements.

Location: Remote in Argentina

Company

hirify.global supports biotech, medtech, and specialty pharmaceutical companies in developing medicines, medical devices, and diagnostics.

What you will do

  • Support the Project Manager with coordination and oversight of cross-functional clinical research project teams.
  • Facilitate internal and external communications, schedule meetings, prepare agendas, record minutes, and manage action and decision logs.
  • Maintain project contact lists, study team lists, system access requests, email distribution lists, and required project systems.
  • Track vendor project budgets, supplies, invoices, out-of-scope services, and change orders.
  • Prepare study newsletters when required and ensure projects remain audit ready.

Requirements

  • Associate’s degree or equivalent in life sciences, medicine, pharmacy, nursing, or a related field, plus at least 2 years of clinical research experience; or a bachelor’s degree or international equivalent, preferably in a clinical, biological, scientific, business, or health-related field.
  • At least 1 year of professional experience in clinical research, healthcare, business, finance, and/or project management is preferred.
  • Basic knowledge of ICH/GCP regulations and project management terminology and guidelines.
  • Working knowledge of FDA guidance documents, EU directives, ISO 14155 regulations, drug and device development, and clinical monitoring procedures.
  • Strong computer skills in Microsoft Office.

Culture & Benefits

  • Remote work from Argentina with flexibility and work-life balance.
  • Opportunities to develop skills and grow professionally.
  • Work that supports the development of medicines, devices, and diagnostics intended to improve patients’ lives.

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