O-1976 CLINICAL PROJECT MANAGER

ADIENNE SA, a biopharmaceutical company based in Lugano is looking for a:

CLINICAL PROJECT MANAGER

Main Responsibilities:

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

Profile:

•    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

Please send your cv to: hr@adienne.com  or apply through our web site www.adienne.com