German Speaker Rwe - Associate Site Manager With Start Up Experience

IQVIA

Sofia, Bulgaria
Fully remote
Remote site monitoring
Site identification and start-up
Regulatory and ethics submissions
Responsible for remote site monitoring activities to ensure sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements

Job Summary

  • Responsible for remote site monitoring activities to ensure sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
  • Performs as needed, initiation, monitoring, and close out visits remotely in accordance with contracted scope of work, using Good Clinical Practices (GCP), applicable regulations, SOPs and work instructions.
  • Reviews the quality and integrity of patient data at assigned sites through the remote review of electronic Case Report Form (CRF) data.

Matching Summary

Responsible for remote site monitoring activities to ensure sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Skills & Requirements

Must-have

  • Remote site monitoring
  • Site identification and start-up
  • Regulatory and ethics submissions
  • Site contract and budget negotiation
  • GCP and applicable regulations
  • Data quality and integrity review

Nice-to-have

  • Collaborative functional group work
  • Independent task management
  • Critical thinking application
  • Effective relationship building

Key Requirements

  • Bachelor's Degree preferred
  • Basic knowledge of clinical research
  • Proficient in English and German
  • Proficient in Microsoft Word and Excel
  • Basic knowledge of ICH and GCP guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter