Olga Konovalenko Email and Phone Number

Conducting of clinical trial projects audits (Trial Master File, Data Management File).Investigational Product Release - quality check of sites and regulatory documents, such as Site Agreements, Investigator Agreements, ICF, CDA, Site team qualification documentation, Laboratory documentation, Site equipment documentation, RA, EC Approvals, etc. (Russia, Europe).Project documents quality check (ICF, CT Reports, DM Reports, Data Management documentation, etc.).Development and maintenance of the company's documentation.

Overall implementation and management of the Quality Management System in the field of clinical data processing. Development and maintenance of the company's documents (all levels of the QMS -Politics, SOPs, Working instructions, standard forms, etc.).Conducting of projects audits.Preparation and participation in customer audits. Preparation and participation in department audits.

Informing project teams/training regarding new regulatory requirements.Review of the documents necessary for submission provided by the client and advising on any amendments of these documents, preparation of the submission package to Regulatory Authorities and Ethics Council, communication with the competent persons in Regulatory Authorities and Ethics Council in Russia. Submission/submission supervision of the applications for the regulatory and ethics approvals, monitoring the status of expert examination and receipt of the expert review summaries and issued approvals. Documents preparation necessary for getting Import License for the study medication and Export Licenses/ submission/Import, Export Licenses receiving.Communication with all applicable Russian Regulatory Authorities in the process of study conduct and provision them with any newly obtained information about the study medication or the clinical trial in line with the local regulatory requirements (SUSAR, New Safety Information, issue of new versions of IB, any amendments to IB, Protocol or Patient Information and ICF, etc.) and getting all necessary supplementary expert opinions, approvals, permissions and licenses.Supervision of documents submission to the Regulatory Authorities and Ethics Councils and obtaining necessary permits for CT in the Baltic States, Ukraine, Bulgaria, Belarus.