Regulatory Submissions (Study Start-up) Manager
1 day left
- Experience Level
- Experienced (non-manager)
Upsilon Global has partnered with one of the top exciting mid-sized CRO who have an opportunity for Regulatory Submissions (Study Start-up) Manager in Israel, to join their team.
They have their own phase 1 unit and focus on drug studies phases I/IV. Unlike a lot of CRO they have their own Bioanalytical Lab (small and large molecule), a Core Imaging and ECG Core Lab and 4 CAP-Accredited Central Labs. 90% of their clients are small medium sized biotech companies.
They have around 4,000 employees across 40 different countries and 32 global offices and have also conducted submissions in over 60 countries. There is a high chance a great opportunity will be offered to you after the first 12 month to work more remotely. They have an outstanding reputation of training, with an excellent opportunity to grow within the company. This is a stable permanent role with competitive salary.
- Efficiently manage and successfully execute all aspects of global start-up.
- Perform quality checks on submission documents and site essential documents.
- Prepare and approve informed consent forms.
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
- Present during bid defences, general capabilities meetings, and audits.
- At least 4 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience.
- Knowledge and experience of Clinical Trial Applications.
- Strong oral and written communication skills.
- Team oriented approach and strong leadership skills; and Fluency in English.
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