Laboratoires Servier For Aixial
- Clinical Data Manager
2012 - 2012Coordinate all data management activities within a project.
Responsible for the coordination of all internal and vendor's deliverables and for completing a project whitin the agred timelines.
ICON Clinical research
- Data Management Project Lead
2010 - 2010
Pierre Fabre for Aixial
- Senior Study Data Manager
2010 - 2012
AAIPharma
- Clinical Data Manager
2008 - 2008- Participation in building and management of clinical databases in accordance with protocol, deadlines, international format (CDISC), SOPs and ICH guidelines.
- Data entry and validation, query review and quality control.
- Adverse event and medication coding using WhoDrug and MedDRA dictionaries.
- Filing of study documentation
- Communication with internal study team members.
AAIPharma
- Clinical Data Manager Lead
2008 - 2010- Coordinate all Data Management tasks within the project
- Perform validation tasks, and be the primary Data Management client contact.
- Responsible for the overall coordination of all internal and client deliverables and for completing projects within budget and on time.
AAIPharma
- Clinical Research Associate
2006 - 2007- Monitoring in various cancer-related phase I and II studies (Melanoma/Colon/Breast cancer)
- Initiation and close-out visits
- Participation in the submission to the Independent Ethics Committee (central and local) in Belgium and in France
- Feasibility studies
- Organizing payment of Investigator grants and site extra costs
- Participation in creation of CRF completion guidelines
- Database validation of phase II and III studies (Melanoma/Colorectal cancer)
- review of data listings and patient profiles
- writing of queries
- Source document verification (medical chart/listing/eCRF) of phase III myeloma study
- Participation in a Compassionate Use Program in GIST indication:
- review of data
- investigator contacts
