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

IQVIA Inc

Germany
**
German language fluency required
Local regulatory submission experience
Site activation and start-up activities
** IQVIA Inc. is seeking a Regulatory and Start-Up Specialist in Germany for a home-based position, requiring fluency in German and experience in local submissions. The role involves overseeing site activation activities, ensuring adherence to regulations, and serving as a key contact for investigative sites and project teams. **

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 GCP/ICH guidelines and applicable German regulatory requirements for clinical trials.

Matching Summary

Match Score: 75

** IQVIA Inc. is seeking a Regulatory and Start-Up Specialist in Germany for a home-based position, requiring fluency in German and experience in local submissions. The role involves overseeing site activation activities, ensuring adherence to regulations, and serving as a key contact for investigative sites and project teams. **

Skills & Requirements

Must-have

  • German language fluency required
  • Local regulatory submission 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 implementation
  • Project timeline review skills
  • Internal systems database maintenance

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 submissions

Work Rights

Not specified

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