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Study Coordinator (m/f) - Germany  

Company managed [?] Still accepting applications

Posted on : 15 June 2017

Project Description

The department of Clinical Diagnostics is seeking a Study Coordinator (m/f) 


Tasks   
  • Design study documents, including protocols, consent forms, clinical site agreements, ethics committee applications, etc. 
  • Prepare clinical evaluation reports, develop partnerships with Clinical Research Organizations (CRO) 
  • Working closely with CRO and Study Principal Investigators to meet study tasks and deadlines 
  • Conduct sponsor oversight visits to assess sites/CRAs in adherence to study plans, protocols and GCP 
  • Monitor study logistics and performance 
  • Collaborate with Regulatory Affairs and Governmental Organizations to comply with new regulations and directives 
  • Facilitate study start with CRO including complete data capture system (eCRF) specifications and development 
  • Organize, host and prepare reports of study maintenance meetings 
  • Resolve study support issues in timely and proactive manner 
  • Work with confidential information and patient data 
  • Communicate progress status and reports to the project manager 
  • Perform data analysis and management   



Qualifications  
  • University degree (PhD or MD) or equivalent in Biology or Medicine 
  • 2+ years of experience in coordination of clinical studies 
  • Ideally, good knowledge of microbiology and understanding of IVD industry 
  • Ability to work in clinical settings 
  • High level of critical thinking, developed skills in problem-solving 
  • Excellent interpersonal and organizational skills, leadership abilities 
  • Entrepreneurial work style, strong attention to details 
  • Demonstrated ability to manage multiple tasks, resolve difficult situations with high degree of professionalism and good judgement 
  • Distinguished English and German skills in both oral and written communications 
  • Travelling (40%)