Is the guarantor of the strategic orientations of BPE which he promotes at all levels. Ensures compliance with the implementation of the BPE operating agreement. Chairs the Executive, Steering and Strategic orientation committees of the platform. Ensures the scientific guidance of the BPE activities. Supports the Director in the management of the teams. Ensures the effectiveness of the Quality Management System.
Ensures compliance with the strategic orientations of BPE, which she promotes at all levels. Ensures conformity of implementation of the operating agreement of BPE. Supervises and organizes the Executive, Steering and Strategic Orientation committees of BPE. Acts as the interface with the partners and the legal services for the implementation of the collaboration agreements. Drafts the estimated budget and ensures budget monitoring to guarantee the financial sustainability of the BPE. Supervises and leads the teams, and monitors the conformity of the projects conducted by BPE. Follows up the activities of the Quality Management System and ensures its effectiveness.
Chief Scientific Officer
Ensures compliance with the strategic orientations of BPE, which he promotes at all levels. Participates in the compliance of the implementation of the operating agreement of BPE. Participates in the Executive, Steering and Strategic Orientation Committees of BPE. Supervises the activity of the Scientific Officers. Designs pharmacoepidemiological projects in compliance with the ENCePP code of conduct and supervises the progress of each stage of the studies.
Designs pharmacoepidemiological studies in accordance with the ENCePP code of conduct, participates in the supervision of the progress of each stage of the studies, interprets and validates their results and participates in the study reports drafting and results dissemination. Provides a scientific watch and also a watch on calls for proposals.
Centralises procedures intended to regulatory authorities, ensures the regulatory watch at national and European levels and supports project teams in regulatory management.
Quality Assurance Manager
Ensures the implementation and monitoring of the quality system and its continuous improvement. Ensures that the Quality Management System complies with the requirements of the ISO 9001: 2015 standard and reports on the performance of the Quality Management System.
Drafts and submits papers to scientific conferences and peer-reviewed journals. Supervises bibliographic research and support for writing scientific articles.
Participates in the design of the research project and ensures the smooth methodological progress of studies it conducts and ensures compliance with cost/quality/timelines. Coordinates the implementation of the project, as well as the statistical analysis, report drafting stages and participates in results dissemination. Leads the team of assistant project managers and team leaders.
Assistant Project Leader
Manages the design of the research project, participates in the development of the budget, manages the operational implementation of the research project. Supervises the team leaders. Participates in the smooth running of the scientific committees, in the follow-up of statistical analysis stages, in the drafting of the study report and in results dissemination.
Participates in the design of the research project and its implementation. Ensures the organization and operational implementation of projects. Supervises the activities of clinical/epidemiological research assistants and administrative agents. Participates in the follow-up of statistical analysis stages, in the report drafting and in the results dissemination.
Research Assistant in charge of "Critical events"
Participates in the definition of diagnostic criteria for events of interest. Investigates events, writes and pre-validates medical observations based on the diagnostic criteria. Organizes and conducts meetings of medical experts validation committees. Participates in the monitoring of the global pharmacovigilance of studies.
Clinical/epidemiological Research Assistant
Ensures the collection and monitoring of data, participates in the quality control of data and tracks investigation centers.
Provides administrative management of the study documents and performs data entry, while participating in certain monitoring activities. The Administrative Team Leader supervises the administrative agents, and manages the activity, participates in the organization of meetings, placing orders and managing missions.
IT Manager/Database Manager
Manages the IT system and infrastructure (management, development and security). Coordinates the development and deployment of data management and transversal IT support tools. Leads the team of database managers/application developers and IT technicians.
Sets up new computer equipment, ensures hardware and software maintenance and provides software support to users. Follows technological developments, monitors the deployment and administration of the backup server. Manages the operation of the electronic equipment.
Participates in the drafting of the database specifications. Develops, tests, installs and maintains IT tools, ensuring data integrity.
Chief of Biostatistics and Data-management
Develops the methodological and statistical parts of the projects. Validates statistical analysis plans, programs and results. Validates data management programs and documents. Ensures the watch on the evolution of statistical methodologies and analysis software. Collaborates in working groups and monitors the evolution of administrative databases. Leads the team of statisticians and data-managers.
Assists the Chief of Statistical and Data-Management in the review and validation of documents and programs for data management and statistical analyses, as well as in the supervision of Statistician-Programmers and Data-Managers, while also ensuring the missions of Statistician-Programmer SAS®.
Participates in data management, writes statistical documents, conducts statistical analyses and participates in the interpretation of study results.
Drafts data management plans, programs data transfers, and checks for data consistency and integrity in field studies, and issues requests for corrections. Manages and controls the SNDS data extractions. Ensures the quality of SAS® data import from field or SNDS databases and participates in quality control of data.
Ensures the follow-up of the administrative management of personnel files and financial management (budget monitoring of operations, budget forecasts and invoicing), follows and controls the accounting operations with the different partners.
Manages supplies orders, payment of fees and organization of missions.
Ensures the organization of meetings, the passage of orders and the management of missions.
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