David Chartier Email & Phone Number

Paris, FR

Boulogne-Billancourt, Île-de-France, France

• Promote the success of clinical trials focused on creating value for patients and research teams by actively contributing or leading communities and work product teamso Sponsor of the Community of Practice Regulatory.
• Actively contribute to all stages for deployment of clinical studies in various therapeutic areas by developing a strategy to ensure the success of clinical trial programso Thorough planningo Effective site.
• Participate in cross-functional projects, dedicated to optimizing processes, strengthening the efficiency of clinical research, identifying and addressing emerging needs
• Promote patient orientation within all Clinical Operations
• Inspire and enhance talent
• Proactively develop partnership and collaborative approaches with all internal and external stakeholders by creating alignment, removing potential barriers and obstacles while applying new ways of working to achieve.

Ville De Paris, Île-de-France, France

• Responsible for the supervision of the Startup and CRA teams
• Responsible for detailed annual performance reviews (mid and end-year), individual development plan or talent development
• Responsible for appropriate management and resolution of performance issues
• Define and measure in country performance indicators
• Assign the workload and engage with resource management
• Oversight of all country-level client deliverables and timelines

• Country regulatory expert responsible of CA submission
• Coordinate and collect of clinical trial study packages and submissions to CA - Activities in coordination with regulatory department, medical team and partners (CRO, distribution site …)
• Primary point of contact near French Competent Authority (ANSM) and head office for regulatory activities
• Subject matter expert country regulations
• Communication to local and international team members (CRA, TL Group, Regulatory group, project’s lead …) by providing trainings/presentations, regular update of regulatory data base, documents associated to SOP …
• Point of contact for internal local SOP review

Paris Et Périphérie

• Responsible for all aspects of study site monitoring including pre-study and site initiation visits, routine monitoring and close-out visits, maintenance of study files, liaison with vendors
• Responsible for all aspects of site management
• Ensure the site is audit readiness at any moment and the investigator oversight is ensured
• Prepared and submit accurate and timely trip reports
• Undertook feasibility or site selections
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation