Clinical Research Manager

   
 

Reporting to: Country Manager
 

Desirable qualifications and background

  • Academic degree in natural science such as medicine, pharmacist biomedicine or similar
  • Experience from pharmaceutical, biotechnology or medical device industries
  • Experience from Clinical Research Organizations (CRO)
  • A well developed understanding for customer care and business development
  • Good ability to express yourself both verbally and in writing
  • Good knowledge of spoken and written English
  • Good organizational skills
  • A service-minded approach
  • Ability to prioritize and handle several tasks simultaneously
Principal duties
  • Lead the study team and ensure that the team members perform their duties according to timelines
  • Planning, co-ordinating and execution of projects
  • Managing project budget
  • Prepare the Clinical Study Documentation together with the study team
  • Organizing study supplies
  • Assist the study team during audits and inspections
  • Prepare and complete applications to the regulatory authorities and ethic committees
  • Prepare and conduct pre-study activities, selection and initiation visits, routine monitoring and closure visits
  • Selecting and negotiating contracts with local/central laboratories, pharmacies etc.
  • Training of staff
  • Planning, participating and leading Investigators meeting
  • Writing and preparing the Clinical Study Documentation


 
 
 
 
 
 

IRW Consulting AB  •  Kungsgatan 64  •  Box 130 78  •  103 02 Stockholm  •  Telephone +46(0)8 791 66 40  •  Fax +46(0)8 758 90 56  • info@irwcro.com

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