11 дней назад
Regulatory and Start Up Specialist - Poland (Clinical Research)
151 200 - 280 700PLN
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Regulatory and Start Up Specialist - Poland (Clinical Research): Coordinating regulatory submissions, site activation, essential trial documentation, and contract negotiations for clinical studies with an accent on Polish regulatory requirements, compliance, and stakeholder coordination. Focus on managing approval timelines, reviewing site documentation, identifying project risks, and supporting efficient study start-up delivery.
Location: Home-based within Poland
Annual base pay: zł151,200–zł280,700
Company
provides clinical research services, healthcare intelligence, and commercial insights for the life sciences and healthcare industries.
What you will do
- Act as the primary contact for investigative sites, Site Activation Managers, project managers, sponsors, and internal stakeholders.
- Coordinate country-specific site activation and regulatory activities for clinical studies.
- Prepare, review, distribute, and track regulatory and essential trial documentation, including ethics submissions, informed consent forms, investigator pack releases, and clinical trial agreements.
- Support contract negotiations, monitor milestones, and identify risks with mitigation plans.
- Maintain accurate records, perform quality reviews, and monitor site performance metrics.
- Provide local regulatory expertise and contribute to process improvement and successful study start-up delivery.
Requirements
- Bachelor’s degree in life sciences or a related scientific discipline.
- Approximately 3.5–5 years of experience in clinical research.
- Strong experience with site activation, regulatory submissions, clinical trial start-up activities, clinical trial agreements, and contract negotiations.
- Knowledge of Polish and international clinical trial regulations.
- Fluency in Polish and strong English communication skills.
- Strong planning, organization, problem-solving, prioritization, and stakeholder management abilities.
Culture & Benefits
- Home-based work within Poland.
- Opportunity to support innovative clinical studies across multiple therapeutic areas and sponsors.
- Global career development and advancement opportunities.
- Collaborative and inclusive environment focused on growth and continuous learning.
- Health and welfare benefits may be provided in addition to base pay.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
11 дней назад
Experienced Clinical Research Associate (m/w/d), Multi-Sponsor, Germany (Clinical Research)
12 дней назад
Associate Medical Director, Medical & Scientific Communications
109 400 - 304 900$
12 дней назад
Senior Clinical Research Associate (IVD/Medical Devices)
103 000 - 130 000$
1 день назад
Clinical Trial Safety Scientist (FSP - Permanent Home Based)
12 дней назад
Clinical Trials Scientific Affairs Supervisor
5 дней назад