Sr Study Start Up Associate

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

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 initial submission and 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.
• Develop and finalize Country Specific SIS/ ICFs.
• Collect critical documents for IP release
• Mentor / train new and junior personnel in SSU.
• Part of Regulatory Intelligence SME Team responsible for Poland.

What you need

• A bachelor's degree or related experience is preferred
• SSU experience is desirable.
• 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.