Clinical Trial Approval Manager

Due to its continuous expansion, Harrison Clinical Research Russia is looking for a Clinical Trial Approval Manager. Candidates would be responsible for:

• collection and filing of all documents essential for clinical trial approval
• compilation of all documentation necessary for and submission to Ethics committees /regulatory bodies
• notification to local authorities
• organisation of patient insurance
• maintenance of the HCR regulatory library
• maintenance of current regulatory guidelines and laws on the HCR server
• liaison and regular meetings with relevant personnel in other HCR offices and sub-contractors

It would be an advantage if you were experienced in clinical trial submissions to ECs and regulatory bodies in Russia and other countries, as would be knowledge of ICH-GCP, the Russian Drug Law and the Medical Device Act.
You have a qualification in a scientific, paramedical, pharmaceutical or biological discipline and are familiar with medical terminology. You are able to plan, set priorities and manage your time well. You can work independently to a high standard, are self-reliant, have a good eye for detail and work well in a team. Your written and spoken English and Russian is good and you have a good grasp of MS-Office applications. 

Clinical Operations

Moscow, Russia