- Senior data team lead
2003 - 2009
Project Management responsibilities:
• Coordination of international Phase III studies
• Interact with Sponsor, team members (CRAS, biostatisticians, programmer, Data managers) and third parties (Lab, ECG, MRI, IVRS…)
• Negotiate and manage timelines and responsibilities.
• Manage out-sourcing to distant offices (India, South Africa).
• Representative of Data Management at project meetings (Investigator's meetings, CRA Trainings, Kick off meetings, Client Meetings).
• Responsible for financial aspect of Data Management Project (Review of scope of work, monthly reports, invoicing, costing of out of scope, use of people soft tool)
• Mentor other team members in training and developing data management activities on specific studies.
• Advanced training of several assistances to use and benefits of e-CRF.
Data Management experiences:
Perform all classical data management tasks:
• CRF design
• Database set up
• Database testing
• Edit checks testing
• Queries management
• Coding MedDRA and WHOdrug
• SAE reconciliation
• Protocol Deviation Specifications
• Data Review and preparation for Medical Review
• Data Handling export / import
• Database lock