Lyon
17+ years of experience in CRO outsourcing, global program operations management and clinical trial coordination acquired within leading multinational biopharma and CRO. Sound knowledge of global regulatory requirements and ICH-GCP. Proven ability to lead in a multicultural and cross-functional matrix organization. Strong interpersonal skills. Excellent team player.
SPECIALTIES
-Clinical Operations:
Global program operations management including budget and resources, cross-functional team and Clinical Trial Managers leadership, activities alignment, adherence to highest quality standards.
-CRO outsourcing:
Timelines and budget definition, key performance indicators, partnership, team leadership and conflict resolution.
-Clinical trial management:
Coordination of multinational and complex phase II and III trials, CRO selection, country and site screening, trial supplies forecasting, clinical trial application and EC submission overview, compliance, team coordination.
-Regulatory environment:
Clinical trial submission, ICH-GCP compliance, ethics commitees, IRBs, FDA and EMA market application.
