Clinical Regulatory Specialist Clinical Research Hungary

5 days ago

Budapest, Budapest, Hungary Carbyne Full time €60,000 - €80,000 per year
A USA-headquartered innovative biopharma company is looking for a Clinical Regulatory professional to serve as Clinical Regulatory Specialist in Hungary. Secure stable employment at one of the most successful global pharmaceutical companies as the first expert in this brand new role.

Responsibilities of the Clinical Regulatory Specialist will include:
  • manage country, study and site level deliverables during start-up and maintenance
  • pepare and develop strategy for start-up activities to ensure successful recruitment and delivery to trial milestones
  • collaborate with other internal roles in country feasibility and site selection
  • collaborate directly with internal study teams, external site staff, country Ethics Committees to ensure tasks and priorities are aligned to the defined study timelines
  • prepare and perform submission for Ethics Committees and Health Authorities
We would love to hear from you if you have:
  • at least Bachelors degree in a life science field or equivalent
  • at least 1-2 years of individual on-site clinical monitoring experience
  • at least 2 years of individual clinical regulatory experience
  • solid understanding of GCP, ICH Guidelines and Country regulatory environment
  • stong organization and planning skills and independent decision-making ability
  • good verbal and written communication skills both in English and local language
Should you be interested in the details of this vacancy feel free to leave a comment with your details or submit your CV for this role.

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