5 дней назад
Regulatory and Start Up Specialist - Serbia
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Regulatory and Start Up Specialist - Serbia (Clinical Research): Performing country-level site activation and regulatory activities for clinical studies with an accent on document preparation, site coordination, and compliance with regulations and SOPs. Focus on tracking regulatory and contractual approvals, maintaining study systems, coordinating project timelines, and performing quality control of site documents.
Location: Home-based role in Belgrade, Serbia
Company
IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Coordinate country-level site start-up and activation activities for assigned clinical studies.
- Serve as the single point of contact for investigative sites, Site Activation Managers, project management, and related departments.
- Prepare, review, distribute, and quality-control regulatory, contractual, ethics, informed consent, and investigator documents.
- Track document approval and execution progress, site performance metrics, project timelines, and study information in internal systems.
- Provide local regulatory expertise during project planning and implement contingency measures when needed.
- Communicate completion of site documents and collaborate with sponsors on specific initiatives.
Requirements
- Based in Serbia and able to work from home.
- Experience with RSU and contracts.
- Knowledge of applicable local and international regulations, SOPs, work instructions, and project requirements.
- Experience preparing and reviewing regulatory documents for completeness and accuracy.
- Ability to manage project timelines, tracking systems, databases, and quality-control activities.
Culture & Benefits
- Home-based work arrangement.
- Work aligned with clinical research quality standards and applicable regulations.
- Collaboration with investigative sites, project teams, management, and sponsors.
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