German Speaker Rwe - Associate Site Manager With Start Up Experience

Ivivamedical

Fully remote
Remote site monitoring
Site identification and start-up
Regulatory document collection and filing
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 site identification, site selection, and site start-up activities including preparing regulatory/ethics submission packages, collecting and reviewing regulatory documents, and negotiating site contracts and budgets.
  • Serves as a primary contact between the business and the investigator site, collaborates with field CRAs, and reviews the quality and integrity of patient data through 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 document collection and filing
  • Site contract and budget negotiation
  • GCP and applicable regulations
  • Communication with investigator sites

Nice-to-have

  • Collaborative functional group work
  • Problem-solving skills
  • Independent task management
  • Critical thinking application

Key Requirements

  • Bachelor's Degree preferred
  • Basic clinical research knowledge
  • English and German language proficiency
  • Basic ICH and GCP guidelines knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter