1 день назад
Country Associate Submissions Representative (Regulatory & Start-Up Specialist), France, IQVIA Biotech
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Country Associate Submissions Representative (Regulatory & Start-Up Specialist) (Clinical Research): Coordinating site start-up and activation activities for clinical research studies in France with an accent on regulatory documentation, ethics approvals, informed consent documents, and compliance with GCP requirements. Focus on tracking site activation milestones, maintaining study systems, performing documentation quality control, and managing project timelines across investigative sites and stakeholders.
Location: Homebased in Paris, France
Company
Biotech supports biotech and emerging biopharma companies with clinical development services across therapeutic areas and development phases.
What you will do
- Coordinate site start-up and activation activities for clinical research studies.
- Serve as the primary contact for assigned investigative sites and project stakeholders.
- Prepare, review, maintain, and quality-check regulatory and essential study documentation.
- Track regulatory, ethics, informed consent, and study-document approvals against project timelines.
- Maintain study information in internal systems, databases, and tracking tools.
- Monitor site performance, support project planning, and provide local regulatory expertise.
Requirements
- Bachelor’s degree in Life Sciences, Health Sciences, or a related field.
- At least 1 year of clinical research experience.
- Knowledge of clinical research regulations, Good Clinical Practice (GCP), and site activation processes.
- Strong organizational, communication, and relationship management skills.
- Ability to manage multiple priorities and meet project deadlines.
Nice to have
- Knowledge of contract amendments and updating informed consent forms.
Culture & Benefits
- Home-based work arrangement in France.
- Collaborative and agile working environment.
- Opportunity to support clinical development for innovative treatments.
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