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4 часа назад

Study Start Up Manager, IQVIA

Формат работы
onsite
Тип работы
fulltime
Английский
b2
Страна
Brazil
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
Study Start Up Manager, IQVIA (Clinical Trial Site Activation): Directing site activation, maintenance, and regulatory activities for clinical studies and multi-protocol programs with an accent on regulatory strategy, project planning, and multi-regional coordination. Focus on resolving regulatory complexity, maintaining study approvals and essential documentation, and ensuring compliant delivery through CTMS and quality management.

Location: São Paulo, Brazil

Company

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

What you will do

  • Direct site activation, maintenance, and regulatory activities for assigned clinical studies and multi-protocol programs.
  • Develop and maintain management plans, project timelines, scopes of work, budgets, and resource plans.
  • Coordinate Regulatory and Site Activation activities across regions and countries.
  • Define regulatory strategies, submission expectations, and required authorizations.
  • Identify regulatory challenges, develop practical solutions, and support bid defense and study execution.
  • Maintain CTMS records, databases, tracking tools, project plans, and essential documentation.

Requirements

  • Experience managing clinical study start-up, site activation, maintenance, or regulatory activities.
  • Ability to oversee multi-regional and multi-protocol programs.
  • Knowledge of regulatory submissions, study approvals, authorizations, contracts, and essential documents.
  • Ability to collaborate with quality management and maintain required quality standards.
  • Capability to provide regulatory and technical scientific support, mentor colleagues, and present or deliver training.

Culture & Benefits

  • Full-time employment.
  • Work supporting the development and commercialization of medical treatments.
  • Collaboration with international regions, countries, clients, and professional bodies.

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