ADIENNE SA, a biopharmaceutical company based in Lugano is looking for a:
CLINICAL PROJECT MANAGER
Responsible for the oversight and the execution of the assigned clinical studies: typically responsible for 1-4 trials (depending on the complexity) from phase I to IV.
• Manages clinical projects from concept through clinical study report completion
• Oversees clinical research study conduct serving as main point of contact for the CRO trial manager, vendors, investigators, monitors and other external partners
• Assures continuity and alignment with the trial objectives throughout the trial.
• Organizes and leads the clinical project team. Leads regularly scheduled cross-functional study team meetings with internal and external resources.
• Participates in CRO and other vendor selection, negotiation and management,
• Leads the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
• Participates in meetings with investigative sites, key opinion leaders and consultants as needed
• Maintains expertise in GCP/ICH/FDA regs/SOP and clinical trial methodology.
• Co-monitors as needed
• Contributes to data listing review, preparation of Clinical Study Reports.
• Works closely with regulatory team; may assist in the preparation of regulatory filings
• Performs other duties as assigned
• Science background MD or BS or healthcare degree
• Minimum 5+ years hands-on experience in a pharmaceutical/biotech or CRO, e.g., as Clinical Research Associate or Clinical Project Manager
• Know-how in managing Phase I, II, III & IV clinical studies
• Experience in writing clinical study protocols, informed consent forms, and other clinical documents
• Strong knowledge of GCP/ICH Guidelines and regulatory requirements for clinical trial management
• Strong interpersonal, organizational and multi-tasking skills.
• Proactive approach to problem solving
• Proficiency in MS Office (Excel, Outlook, PowerPoint and Word)
• Excellent team working attitude
Languages required: Italian and English