Mes compétences :
Clinical research
Project management
Cardiology and rhythmology
MRI: Safety and Compatibility of Medical Devices
Engineer
Medical device
Entreprises
iSTAR medical
- Clinical Operations Senior Manager
Rungis 2017 - 2018Manage multiple international post-market studies
Lead clinical project teams
Manage CT.gov posting
Contribute to the development of the study protocol, training plan/requirements and other study related documents
Ensure project quality
Engage key opinion leaders and internal senior leadership
Serve as a mentor to CRAs
Participate to special projects (task forces...)
Contribute to the development and execute the publication strategy
Comply with appropriate regulatory requirements
St. Jude Medical
- Clinical Manager
Boulogne-Billancourt2015 - 2016Manage multiple international post-market studies
Lead clinical project teams
Manage CT.gov posting
Contribute to the development of the study protocol, training plan/requirements and other study related documents
Ensure project quality
Engage key opinion leaders and internal senior leadership
Serve as a mentor to CRAs
Participate to special projects (task forces...)
Contribute to the development and execute the publication strategy
Comply with appropriate regulatory requirements
St. Jude Medical
- Associate Clinical Manager
Boulogne-Billancourt2013 - 20151. Clinical trial management:
Design, implement and manage international clinical studies (timelines, budget)
Provide clinical scientific support (training)
Ensure compliance with appropriate regulatory requirements
Initiate communication with other departments
2. Clinical data management:
Oversee interpretation of clinical results and preparation of study reports, presentations and publications
Provide oversight and support to investigators for papers and presentations
Identify and access key opinion leaders
Interface with regulatory authorities
3. Personnel management:
Provide leadership to clinical research staff
Manage personnel resources to support project activities
Provide guidance and support to direct report
Identify and create career growth opportunities for direct report
St. Jude Medical
- Clinical Project Leader
Boulogne-Billancourt2011 - 2013Manage international clinical studies (timelines, budget)
Lead and train the project team
Develop/coordinate project management plan and all project associated documents
Coordinate administrative activities
Define requirements and coordinate service providers
Define requirements for committee membership, investigator and center participation to project
Coordinate centers selection, nomination and initiation
Coordinate monitoring activities, timely and quality data collection
Perform data verification
Coordinate data analysis
Plan and support scientific communication
Coordinate and communicate with investigators/physicians boards
Ensure compliance with appropriate regulatory requirements
Sorin
- Clinical Project Manager
Paris2010 - 2011Manage international clinical studies (timelines, budget)
Write study documents
Coordinate site selection, qualification and initiation
Coordinate regulatory submissions and administrative activities
Coordinate monitoring activities
Organize training sessions
Manage steering committee, physicians board and investigator meetings
Interact with cross-functional team
Lead the project team
Ensure compliance with appropriate regulatory requirements
Sorin
- Clinical Research Engineer
Paris2003 - 20101. Design and clinical evaluation of new functions in treatment and diagnosis:
Research new concepts
Write patents
Write clinical specifications
Define and implement preclinical and clinical strategy
2. Clinical project management:
Write clinical protocols
Manage budget and planning
Coordinate and train the project team
Provide technical support
3. Exploitation of technical and clinical data:
Perform data analysis
Write clinical reports
Write scientific publications
Formations
Society Of Clinical Research Associates (SOCRA) (Chalfont)
Chalfont2015 - 2018Certified Clinical Research Professional
