Specialists in Pharma, Clinical & IT Recruitment

Clinical Study Manager (CSM)

Reference:
EH-014
Job Type(s):
Clinical Operations
Salary:
Salary negotiable
Town/City:
Near Frankfurt
Contract Type:
Permanent
Date Posted:
18/12/2012 09:32:00
Start Date:
18/12/2012
End Date:
28/02/2013

Description

My client is a young and successful biopharmaceutical company located in Germany, developing innovative therapies. They require Clinical Study Manager CSM to be based near Frankfurt.

 
The Role:
You will be responsible for the execution of our phase Ib, II and III clinical studies, mainly with regard to operational and administrative aspects. This implies the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs. You will be responsible for the timely performance of all services, control of third party providers, as well as problem management by interacting with all departments involved.
 
  • Oversight on project timelines, quality and deliverables
  • Support in preparation of regular status reports to the management
  • Contribution to and review of study documents, e.g. synopsis, investigator’s brochure, patient informed consent documents, site instruction manuals etc.
  • Co-ordination of project activities with other departments
  • Handling of contract negotiations with trial sites/ pharmacies/ local labs in Germany
  • Preparation and conduct of project trainings
  • Organisation and conduct of team meetings
  • Organisation and participation in investigator meetings
  • Generation of a project database
  • Processing of all relevant issues of the national and international ethics committees and regulatory authorities in adherence to the timelines
  • Effective internal and external project communication

The Requirements:

  • Natural/ life sciences or medical background (university degree or experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant)
  • Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP)
  • Minimum 2 years of experience in project management, regulatory submissions, monitoring of clinical trials or clinical trial assistance
  • Refined colloquial and correspondence skills in German (written and spoken)
  • Fluent in English (written and spoken)
  • Experience in usual software (Word, Excel, Power Point, MS Project)
  • Ready to take over responsibility, pro-active way of working
  • Able to motivate and lead a team / used to work in a team
  • Excellent organisational skills

Please contact Emma Hobbs +44 1483 397070 emma@arc-7.com to discuss this position in more detail.

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