4 часа назад
Study Start Up Manager, IQVIA
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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