Regulatory And Start Up Specialist 2 - Germany - Home Based (m/w/d)

IQVIA UK

Germany
**
German language fluency required
Local regulatory submissions experience
Site activation and start-up activities
** IQVIA UK is seeking a Regulatory and Start-Up Specialist for a home-based position in Germany, focusing on site activation activities in accordance with regulations and project requirements. The ideal candidate should have a background in clinical research, fluency in German, and experience with local submissions. **

Job Summary

  • This role serves as the Single Point of Contact for investigative sites to ensure adherence to local regulations and project timelines.
  • The specialist is responsible for preparing, reviewing, and distributing regulatory documents including Informed Consent Forms and Investigator Packs.
  • Candidates must possess in-depth knowledge of clinical systems, GCP/ICH guidelines, and applicable German regulatory requirements.

Matching Summary

Match Score: 75

** IQVIA UK is seeking a Regulatory and Start-Up Specialist for a home-based position in Germany, focusing on site activation activities in accordance with regulations and project requirements. The ideal candidate should have a background in clinical research, fluency in German, and experience with local submissions. **

Skills & Requirements

Must-have

  • German language fluency required
  • Local regulatory submissions experience
  • Site activation and start-up activities
  • GCP/ICH regulatory guidelines knowledge
  • Single Point of Contact responsibilities

Nice-to-have

  • Direct contact with sponsors
  • Contingency planning skills
  • Project timeline management expertise

Key Requirements

  • Bachelor's Degree in life sciences or related field
  • 3 years' clinical research or relevant experience
  • Fluency in German language
  • Knowledge of local regulatory requirements

Work Rights

Not specified

Tailored Resume

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