Regulatory Submission Manager
|Job Title:||Regulatory Submission Manager|
|Contact Name:||Karl Paddley|
|Job Published:||July 25, 2016 12:09|
My client is a US owned global CRO expanding rapidly across Europe. With a strong reputation across Western Europe the company are expanding operations in Russia and is an exciting time to be part of the regulatory study start up team.
This company have a fantastic reputation and are renowned for developing their staff and providing great career opportunities. This is an excellent opportunity for someone with 5+ years study start up experience in a large CRO environment.
This position must be office based in St Petersburg.
Manage and execute all specifications set by client sponsor for global start up activities
QC check submission documents and essential site documents
Preparation and approval of informed consent forms
Continuous review and knowledge update of regulations in order to be able to develop and deliver pro-active solutions to start-up problems and challenges
Support bid defense meetings and audits
5+ years in clinical research area ideally in a global CRO environment.
Strong knowledge and experience in clinical trial applications within EU
Strong communication skills
Fluent in English
If this role is of interest then please apply or alternatively give me a call on +44(0)1737 236761
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