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Clinical Start-up Manager (or Senior Officer) - Qualitis Ltd
Τρίτη 27 Μάρ 2018
Qualitis Ltd requires for immediate employment a Clinical Start-up Manager (or Senior Officer) (Position Code: Q/CSS/CL), who will be fully involved in the following

a) start-up phase of the interventional trials of an International Pharmaceutical Company in Athens and

b)  support of the pharmaceutical products of the Regulatory Affairs Department.

Our Company provides an excellent benefits package, including:

  • Competitive Salary
  • Private Health Insurance
  • Annual Bonus

Job responsibilities mainly include:

  • Development and follow-up of submissions and amendments to the relevant Authorities (Hospitals, EOF, National EC), in cooperation with above-country operational hubs and local clinical operations or third party vendors
  • Maintenance activities for the lifecycle of the Clinical Trial Application including response to Regulatory Authority queries
  • Management of the contract and budget processes in compliance with the appropriate guidelines and local regulations
  • Maintain product related document management systems & databases (Global and Local)
  • Support of the Regulatory Affairs Department’s processes and procedure

The ideal candidates should fulfill the following qualifications/requirements:

  • Hold a University Degree, preferably in Health Sciences
  • A minimum of three (3) years of experience in a similar position in the Pharmaceutical Industry/CRO Sector
  • Experience in Regulatory Affairs of pharmaceutical products will be a strong asset, but not a prerequisite
  • Excellent computer literacy with the MS Office Suite
  • Ability to multitask and work in a fast-paced environment
Candidates should send their CVs in English indicating the position code, at info@qualitis.gr
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