Cra - Region Leipzig

Syneos Health

Leipzig, Germany
Fully remote
Ich-gcp and gpp compliance
Site qualification and initiation
Monitoring and site management
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance

Job Summary

  • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
  • Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.

Matching Summary

Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.

Skills & Requirements

Must-have

  • ICH-GCP and GPP compliance
  • site qualification and initiation
  • monitoring and site management
  • protocol compliance
  • subject safety and data integrity
  • Source Document Review
  • Investigational Product management

Nice-to-have

  • passionately changing lives
  • Total Self culture
  • diversity of thoughts and backgrounds
  • problem solvers innovating as a team
  • agile and driven to accelerate delivery

Key Requirements

  • Bachelor's degree or RN
  • 3 years on-site monitoring experience in Germany
  • Fluency in German and English
  • Ability to manage required travel

Work Rights

Not specified

Tailored Resume

Cover Letter