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
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.
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