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
Vigneux-sur-Seine (91270)
Employed
Available
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.
CEO
JV3D
Since November 2021
- Creation and management of the company
- 3D design
- 3D printing
University lecturer
Sorbonne University
Since October 2013
Consultant
Paris
France
- 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.
Data Manager
Sanofi
April 2020
to October 2021
Consultant
Montpellier
- Phase II studies
- Neurology and rare disease
- International operational teams (vendors) management and support
- International CRO management for Data Management activities
Senior Project Manager
Median Technologies
January 2020
to February 2020
Full-time
Sophia-Antipolis
France
- Management of imaging projects
- Line management (3 employees)
- Bid defense with sponsor
Service Delivery Lead
Cognizant Technology Solutions
July 2018
to January 2020
Full-time
Paris
France
- 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
Clinical Data Project Manager
Cognizant Technology Solutions
November 2013
to June 2018
Full-time
Paris
France
- 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
Clinical Trial Operations Manager
Sanofi
November 2011
to October 2013
Consultant
Chilly-Mazarin
France
- 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)
Data Operations Coordinator - Data Management
Quintiles
May 2010
to October 2011
Full-time
Illkirch-Graffenstaden
France
- 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
The objective is to train clinical research assistants (CRAs) who are responsible for monitoring clinical trials of drugs.
Learn more
Master Business Administration (MBA)
Graduate Sorbonne Business school
September 2009
to September 2010
This generalist qualification aims to bring another management skills to young graduates of higher education. It is part of a continuity of study and completes the initial degree of the student, allowing them to benefit from double positioning professional competence as sought by companies. In existence for nearly half a century, the MBA has naturally found its place within professional diplomas that issue the IAE within Universities. Real career booster, general management degree, 2nd competence training, the MBA of the IAE de Paris leads logically to the international level by the term "MBA", Master of Business Administration.
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Master degree on Health-Biology (Biotechnologies)
University Montpellier 2 Sciences et Technique du Languedoc
September 2007
to June 2009
Master Biology and Health training is co-authorized by the University of Montpellier 1 and Université Montpellier 2. The M1 is common to the specialties offered in M2. Four different specialties are open in M2: a specialty Research (BIOMED M2R) and 3 professionalizing specialties (Biotechnology, Food Nutrition in Public Health, Industrial Pharmacy).
Skills
Management
- International client management
- Leadership
- Team management (line and operational management)
- International team management (India, South Africa, Hungary)
- Process creation and improvement
- SOP/SWI documents writing and validation
- Administrative management
- Conflicts management (identify, clarify, provide)
Clinical Research
- Main point of contact for client
- Written and Oral Communication (sponsor, vendor, CRO, monitoring team...)
- GCP accreditation
- Clinical study set-up, conduct and close-out management
- CDISC uses
- GDPR compliant
Therapeutic areas
- Oncology
- Diabetes
- Asthma
- Multiple sclerosis
IT
- ITIL foundation
- Service Now (user)
- Automation and Transformation Management
- Incident Management
- Knowledge Transition Management
- Change Management
Languages
- French
- English
- Spanish
Informatic
- MS Office (Word, Excel, PowerPoint)
- MS Project Plan
- SAS / SQL programming
- Rave Medidata
- Oracle Clinical and RDC
- Inform
- OpenClinica
- Formedix
- ServiceNow
- Photo editing (TheGimp, PhotoShop, Affinity Photo)
- Video editing (Pinacle, Final Cut Pro)
- Vector images creation (Inkscape)
- Austria
- Czech Republic
- England
- Germany
- Hungary
- India
- Italia
- Portugal
- Slovakia
- Spain
- Usual Suspect
- Contre Enquête
- Ne le dis à personne
- Deux jours à tuer
- Le Zèbre
- Le nom des gens