Provide input to study risk assessment and propose appropriate and tailored risk indicators for central analysis, in line with holistic data monitoring model Create and own the Central Monitoring PlanSupport set-up and testing of data analysis platformReview clinical study data to identify potential site performance and site organization issuesTrain and support the project teams about interpretation of Central Monitoring outputs and relevant decision making for study conduct Manage operational risk log for Clinical Risk Management activitiesCommunicate effectively with the project team, CRAs, Project Managers, Clinical Trial Managers, DM Staff, Medical Staff, Scientific Council to ensure adequate decisions are taken about the study monitoring strategy and effective resolution of site performance issues Oversee Clinical Risk Management project budget, scope of work, forecasting

Liaises with the Clinical Manager, Project Manager, Clinical Research Monitor, Data Manager and Medical Monitor to ensure the escalation of observations of key risk indicators. Provides specifics regarding trends and safety risks associated with the observations and provides recommendations for next steps and/or resolution.

My responsibilities include assistance in preparing clean databases, including processing of discrepancies and queries. I am also involved in the preparation of the Data Management Plan. Review of CRFs, data listings, and database to ensure that all captured data follow the rules outlined by the protocol and data management plan. Generate paper and electronic queries to appropriate internal or external personnel (investigational sites, vendors, Clinical Research Associates (CRAs), client representatives) to resolve problematic data identified during every aspect of the data management process.I am equally involved in responses review to queries for appropriateness, resolves any discrepancies and modifies the database accordingly and assist in developing a standard set of test data for use in testing data entry screens, data listing presentation, and programmed logical edit checks, as required.In my department (Data management), we are responsible for the documentation set-up noting the testing changes and to perform follow-up testing to validate that the changes have been made, as required.

Performs pre-analytical and analytical genetic technology methods: SNP-karyotyping, DNA - analysis, NGS – sequencing, cytogenetic methods

Theoretical lecture courses on Selected chapters of microbiology,Classical and molecular approaches to taxonomy of eukaryotic microorganisms, Bioinformatical methods in comparative genomics of eukaryotes, Doctoral exams on English and French, Literature review retrieval and experimental work according to thesis goals and timelines, Thesis redaction,Training graduates and pedagogical work with students.