Votre navigateur est obsolète !

Pour une expériencenet et une sécurité optimale, mettez à jour votre navigateur. Mettre à jour maintenant

×

Vincent CAPELLE

Vincent CAPELLE

Clinical Project Manager

Clinical Data Management
Clinical IT Support Management
Clinical Study Project Management
International Team Operational and Line Management
41 years old
Driving License
Jonquières (34725) France
Employed Available
Contact me
Multi-skilled in clinical research (clinical activities, data management, application support) I have been working in clinical research for 10 years from Data Manager up to Project Manager and I would like now to meet new challenges.
Home Experiences Education Skills Interests
Download my PDF resume
Experiences
  • Creation and management of the company.
  • Support creators, whether they are artists or industrial designers.
  • 3D printing, FDM, SLA, FGF, SLM, SLS
  • 3D design, Fusion360, Shapr3D
Company Description
JV3D is a 3D design studio specializing in supporting creators, whether they are artists or industrial designers. JV3D leverages its expertise from prototyping to the industrialization of your project, enabling control over timelines, quality, and costs.
Company website
http://www.jv3d.fr
  • Introduce clinical research to a 20-student classroom
    Present and explain the main jobs working on the clinical research
    Make the clinical research interesting for students who barely know about it and who have a negative image from it
  • Introduce the Data Management activities to a 200-future CRA classroom.
    Present and explain the role and actions of the Data Management team and make the future CRA understand better about their future colleagues as today there is a gap between CRA and DM understanding.
  • Phase II studies
  • Neurology and rare disease
  • International operational teams (vendors) management and support
  • International CRO management for Data Management activities
  • Management of imaging projects
  • Line management (3 employees)
  • Bid defense with sponsor
  • IT Support Management
  • Overview of set of 160 clinical applications
  • First point of contact for application owners and domain leaders (customer)
  • Application support transition (Knowledge transfer and Knowledge Acquisition)
  • Automation and elimination management
  • Enhancement and improvement of the application's support
  • Identify and create metrics and dashboards for efficient reporting
  • Internal and external reporting on the deliveries (KPI)
  • Onboardin/Offboarding of application in portfolio
  • Line management
  • Project management (budget, resource, timelines)
  • Phases I, II and III study management
  • Asthma, diabetes, oncology therapeutic areas
  • Set-up, Conduct and Close-out phases
  • First point of contact for sponsors (pharmaceutical companies)
  • CRA training (material and presentation)
  • Support to operational teams (near-shore - Budapest, and offshore - India)
  • Process review and optimization
  • Documentation review and optimization
  • Third Party Vendors management
  • Development of new data management tools (reporting)
  • CDISC, SDTM conversion management
  • eTMF management

Data Manager

Danone
July 2013 to October 2013
Consultant
Palaiseau
France
  • Consulting on behalf for Aixial Pharma
  • Set-up of clinical study in Japan
  • eCRF design (Formedix - Rave Medidata)
  • Documentation writing and reviewing (synopsis, protocol, specifications...)
  • CRO and vendor management
  • Paper-based study, phase IIIb, on Oracle Clinical 4.5 (multiple sclerosis) with CDISC
  • Dedicated contact for local clinical teams
  • International operational teams (vendors and monitoring teams) management and support
  • International CRO management for Data Management activities
  • Study documentation review (CRF, guidelines, Monitoring plan, load specifications...)
  • Core phase lock organization and extensions set-up
  • Validation plan review (edit checks, SAS checks)
  • Medical review meetings lead and follow-up
  • Safety (SAEs) and external vendor data reconciliation processes optimization
  • Biostatistics issues review and follow-up
  • SAS listings programing for data review (medical review, discrepancies follow-up)
  • Phase IIIb paper based clinical study set-up and coordination with CDISC
  • Set-up, conduct, and the lock of the study
  • Guidelines creation
  • Validation plan creation, correction, and validation (edit checks)
  • International operational teams (vendors, sponsor, and monitoring teams) management
  • Validation documents (CRF, DCF) follow-up with internal team
  • Clinical data review, clarifications requests, database updates according to answers
  • Medical terms coding and review (MedDRA and WhoDrug)
  • External vendors data reconciliations
  • Safety data reconciliation follow-up
  • Internal and external audit preparation
  • Database lock management
  • Association Act 1901 Model Junior Company specialized in advising companies in the areas of education from IAE in Paris.
  • Set up the meetings of governing bodies of the Association (General Assembly ...).
  • Writing reports.
  • Supervise maintenance and update of files relating to members of the association.
  • Identify and analyze all the data strategy, business intelligence and technology to recommendations for the medium-term development of the association.
  • Writing reports from AC & GA
  • Responsible members (assessment, monitoring, call ...).
  • Management and monitoring of projects internally.
  • Administrative preparation of the audit.
  • Development of a protocol for transfection of stem cells in cell therapy of sensorineural deafness.
  • Using molecular biology techniques (microarray, RT-PCR, qPCR, cloning, DNA extraction, Southern blot).
  • Using techniques of cell biology (primary cell culture, flow cytometry, micro-dissection, transfection, transformation).
  • Maintaining line of mutant mice.
  • Using microscopy techniques (fluorescence, scanning electron microscopy, time lapse, ApoTome).
  • Laboratories Max F. Perutz at the Campus Vienna Biocenter were created to form a new research institute in the field of biotechnology with groups from the University of Vienna and Medical University of Vienna.
    Created to pool the expertise of more than 50 research groups in Molecular Biology (in seven thematic areas) Perutz's laboratory represents a new and innovative approach to strengthen research and training at the university.
    Perutz's laboratory is strongly focused on the promotion of young scientists, cooperation between the campus and other research institutes and companies and intends to implement the central science.
  • Study and characterization of a membrane protein in mice.
  • Using various techniques of molecular and cellular biology (PCR, Western blot, cloning, transformation).
  • McDonald's is an Americans chain of fast food, the largest in the world. Although McDonald's did not invent the hamburger or fast food, its name is almost synonymous. With more than 31 600 restaurants worldwide, this brand has become a symbol Globalization and the dominance of American culture as the firm Coca-Cola. Its headquarters is located in Oak Brook a suburb of Chicago, Illinois in the United States.
  • Supports client relationship.
  • Site preparation and management of a team.
  • Placing ads on point of sale.
  • Various animations (birthdays, creative workshops ...).
twitter facebook linkedin