Ctis (clinical Trial Information System) - Team Specialist

Roche UK

Riga, Latvia
2,400 eur grosspmnthly
**
Manage eu cta submission portal
Coordinate eu clinical trial applications
Monitor incoming information from regulators
** Roche UK is seeking a Clinical Trial Information System (CTIS) Team Specialist in Riga, Latvia, to manage EU Clinical Trial Applications and related processes. The role requires strong communication skills, attention to detail, and relevant experience in the pharmaceutical or biotech industries. **

Job Summary

  • As a CTIS-team Specialist, you will manage the administration of the EU CTA submission portal, coordinate and support the compilation, completion and submission of EU Clinical Trial Applications (CTAs) and CTA related information.
  • This is a one year Fixed term position, were you will be focusing on creating initial CTAs and handling post-approval activities throughout the CTA lifecycle, including modifications and adding new countries in CTIS.
  • In Exchange we provide you with development opportunities, excellent benefits & flexibility, and a global diverse community.

Matching Summary

Match Score: 75

** Roche UK is seeking a Clinical Trial Information System (CTIS) Team Specialist in Riga, Latvia, to manage EU Clinical Trial Applications and related processes. The role requires strong communication skills, attention to detail, and relevant experience in the pharmaceutical or biotech industries. **

Salary

2400 EUR gross/monthly

Skills & Requirements

Must-have

  • Manage EU CTA submission portal
  • Coordinate EU Clinical Trial Applications
  • Monitor incoming information from regulators
  • Track and archive HA inquiries
  • Proficiency in IT skills
  • Data and document management skills

Nice-to-have

  • Experience in biotech or pharmaceutical industry
  • Additional languages a plus
  • Assess automation opportunities

Key Requirements

  • Minimum BA or BS degree in biology, chemistry, pharmacy, or related field
  • Previous experience with regulatory data, documents and dossier structures
  • Strong communication skills in English (written and spoken)

Work Rights

Not specified

Tailored Resume

Cover Letter