Medical Advisor - Homebased, Italy

Main functions

• Performance of Pressure test activities, Feasibility, Feasibility-Follow Up, identifying Additional sites and New sites for international protocols within the Cluster by collecting information and documentation on the study to be performed, and by conducting surveys with opinion leaders or potential investigators according to International Clinical Development (ICD) and GMA requirements and timing. Ensure that the clinical studies running the country are in accordance to the Medical practice, and meet the Ethical & Deontological Medical standards
• First-line medical support to the CSU team e.g: answer medical questions from investigating sites, answer questions from Ethics Committees/ Health Authorities.
• Ensure scientific training and medical mentoring to the monitoring team within the Cluster.
• Maintain and expand the investigator network in Italy.
• Promote participation of the country and satellites countries in early phase studies (0, I and IIa).
• Contribute to the exchange of relevant information between R&D, Medical Marketing and the Business Unit regarding the clinical operations activity of the CSU and ensure the handover of R&D products to marketed compounds.
• Support the affiliate network of KOL when selecting National Coordinators or members of study committees.
• CSU preferred point of contact for ICD to provide input on Clinical Development Plan and medical practices (e.g. review of synopsis).
• Close collaboration with Support Services Manager (SSM), CPL, Team Managers, CTA-Regulatory Manager and CRA for starting-up activities, during the study conduct issues and recruitment follow-up.
• Collaborate with Team Leaders for CPL assignment and site selection process.
• Close collaboration with Team Managers, CPL, and SSM for study budget preparation for R & D - CSO and GMA studies. 
• Provide qualitative review for Safety follow-up.
• Collaborate to establish inter-affiliate synergies.
• Liaise with Italian team to perform feasibility evaluation.
• Role evolution, transversal role functions and new ways of working according to priorities.

Requirements

• Background: Qualified Medic (MD)

• Knowledge: Previous experience in clinical research, good clinical practice (GCPs) + ICHs and local + Company SOPs. Business, knowledge in pharmaceutical industry, product development, legal/regulatory framework, medical/clinical project management, therapeutic knowledge.

• Language (language and knowledge level): Fluent in English.

• Professional experience: Experience in clinical research is preferable.