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Project Manager - United States, Germany, India  

Company managed [?] Still accepting applications

Posted on : 10 April 2017

Project Description


Roles and Responsibilities
  • Management of national and multinational clinical  trials including                               
    • Planning of clinical trials as regards contents, regulatory compliance and administrative and logistic aspects 
    • Interface management 
    • Management and co-ordination of CRAs:  
  • Coordination of national or multinational multi center trials 
  • Supervision of GCP compliance  
  • Supervision of trial conduct, as regards monitoring, safety aspects, timelines, and trial budget  
  • Prospective and timely troubleshooting    
  • Continuous communication during the project with the  sponsors and internally at EA 
  • Cooperation with data management, biometrics, medical  writing, medical services and pharmacovigilance, quality assurance and other  functions at EA or vendors 
  • Participating in and responding to in-house  inspections and audits in collaboration with EA’s QA Department 



Requirements
  • At least 3 years of experience in planning,  conducting, supervising and evaluating clinical trials in accordance with GCP –  preferably from another CRO.   
  • Analytical mind-set and a strong talent for planning,  organising and executing trial activities 
  • Excellent communication, organisational skills and  team leading skills 
  • Ability to quickly understand medical issues within  different therapeutics areas 
  • Good understanding of clinical research methodologies 
  • Very good command of written and spoken English.  Command of other one or more European language will be an asset 
  • Understanding of regulatory procedures and guidelines  in Europe 
  • Study  of natural science (biology, medicine, pharmacy or nursing) or equivalent –  e.g. Bachelor, Master or Ph.D. level