12 часов назад
Regulatory and Start Up Specialist - Austria
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Regulatory and Start Up Specialist - Austria (Clinical Research): Perform country-level site activation and regulatory activities for clinical studies with an accent on document management, regulatory compliance, and study timeline coordination. Focus on preparing and quality-checking site documents, tracking regulatory and ethics approvals, and providing local expertise to project teams in Austria.
Location: Home based in Austria; Vienna, Austria. German language fluency required.
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 regulations, SOPs, work instructions, and project requirements.
- Prepare, review, distribute, and quality-check regulatory, contractual, ethics, informed consent, and investigator pack documents.
- Maintain project information in clinical systems, databases, tracking tools, and internal records.
- Track document approvals, execution, and site progress against project timelines.
- Support planning, monitoring measures, contingency planning, and communication of site performance and deliverable status.
Requirements
- Bachelor’s degree in life sciences or a related field and 3 years of clinical research or relevant experience, or an equivalent combination of education, training, and experience.
- Fluency in German is required.
- In-depth knowledge of clinical systems, procedures, and corporate standards.
- Knowledge of GCP/ICH and applicable local and international regulatory guidelines.
- Understanding of the regulated clinical trial environment and drug development process.
- Ability to follow SOPs, maintain quality, and manage project timelines.
Culture & Benefits
- Home-based work arrangement in Austria.
- Work within a global provider of clinical research and healthcare intelligence services.
- Responsibilities include collaboration with sponsors, investigative sites, and cross-functional project teams.
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