Study Start Up Associate II - Medical Devices
About the role
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As a Study Start Up Associate I "Medical Device" 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 trials on pre-market or post-market Medical Devices.
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 trials or late phase studies authorizations and approvals.
- Collect critical documents for MD release.
What you need
- A bachelor's degree or related experience is preferred
- 2 year of SSU experience in Medical devices area.
- Local language 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, but required in Medical Device area.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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