1 день назад
Regulatory and Start Up Specialist - Netherlands
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Regulatory and Start Up Specialist - Netherlands (Clinical Research): Performing country-level site activation and regulatory start-up activities for clinical research studies with an accent on Dutch submissions, contract negotiations, and document quality. Focus on coordinating investigative sites and project teams, tracking regulatory and ethics approvals, and maintaining study timelines and internal systems.
Location: Home-based role in the Netherlands; Amsterdam, Netherlands
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Serve as the single point of contact for investigative sites, Site Activation Managers, project management, and other departments.
- Perform country-level start-up and site activation activities in line with applicable regulations, SOPs, work instructions, and project requirements.
- Prepare, review, distribute, and maintain regulatory, ethics, informed consent, investigator pack, and contractual documents.
- Track document approvals, execution, and site progress against project timelines.
- Maintain internal systems, databases, tracking tools, project plans, and site performance metrics.
- Perform document quality control, support contingency planning, and provide local expertise to project teams.
Requirements
- Dutch fluency is required.
- Experience with local regulatory submissions in the Netherlands is required.
- Experience with contract negotiations is required.
- Experience in site activation, regulatory document management, or clinical research operations.
- Ability to work with SOPs, work instructions, quality requirements, project timelines, and tracking systems.
Culture & Benefits
- Home-based working arrangement within the Netherlands.
- Work connected to the development and commercialization of innovative medical treatments.
- Collaboration with investigative sites, sponsors, project management, and cross-functional teams.
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