
Line manager of 14 CRAs including trainee, junior and senior CRA profiles. In charge of interview, onboarding, KPI & quality follow up, promotion & career development/ Single point of contact with customer partnership/In charge of internal communication/ Resources and deliverables management / issue escalation & reporting to senior management team
Team leader at study level for data management activities. In charge of database maintenance (specification, validation & reconciliation)/ planning & budget management / tools & guidelines update/quality & milestone deliverables follow-up. Single point of contact with customer, operational team, functional lead, project manager, and all other stakeholders.
CRA with full monitoring activities, start-up activities and feasibility. Participation to multiple investigators meeting in Europe. Temporary authorization for use management.
CRA with full monitoring activities/ Regulatory & budget lead activities in France and in Belgium
Leadership & Relationship
Communication & teamworking
Problem solving
Customer focus
Resource management
Schedule & financial skills
Stakeholders’ management skills
Risk & quality management
reporting & analytical skills
forecasting skills
CRA Productivity and performance evaluation: planning & scorecard
Data management activities: database maintenance/migration
Full Monitoring for clinical activities (site selection, site initiation, site monitoring and site closure)
Start-up activities (budget submission, contract review, and regulatory submission to EC and RA)
Feasibility
Temporary Authorization for Use
Oncology (solid tumor and multiple myeloma), infectious (hepatitis C), neurology/CNS (axial spondylarthritis, fibromyalgia, epilepsy), others (renal impairment, smoking cessation, tuberculosis)
Phase I (data management only), II, III and IV
Every two years: Barnett international GCP for expert’s certification
2024: Project Management Professional (PMP training) with PM Institute & Education First Training (EF- English training)
EDC system: Rave (Medidata), oracle (inform), rightrack, paper, CTMS, Pack office (word, excel, powerpoint), SAS universal.