Study Start Up Associate I

Employer
ICON Clinical Research
Location
Vienna
Salary
Competitive
Closing date
23 Sep 2020

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Discipline
Clinical Research, Study Start Up
Hours
Full Time
Contract Type
Permanent
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As a Study Start Up Associate I at ICON, you'll work as a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.

The Role
  • To review and negotiate clinical site investigator contracts and budgets.
  • Stay connected with Investigative sites, sponsors and internal personnel regarding the status of contracts and contract-related documents
  • Prepare and coordinate preparation of contractual documents and correspondence
  • Facilitate the indemnification process between the study sponsor and the site.
  • Perform regulatory document for maintenance e.g. amendments, periodic updates and safety letters.
  • Prepare, review, submit and QC submissions to ethics, regulatory and other authorities to obtain clinical trial authorizations and approvals.
  • Collect critical documents for IP release.


What you need
  • A bachelor's degree or related experience is preferred
  • SSU experience is desirable but not required.
  • Excellent German and English language skills
  • Experience in a clinical research environment with specific experience in study submissions or contracts review and budget negotiation or in related field such as where submissions or contract or legal document review is a primary part of you role.

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.

We are a global provider of outsourced development and commercialisation services to pharmaceuticalbiotechnologymedical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.

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Contact Us
  • 3rd Floor
  • Marlow International
  • Marlow
  • SL7 1YL
  • United Kingdom
  • 01628 496300
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