How we work

I coordinate clinical development understanding projects needs and developing innovative solutions for the assigned organizational unit.

My typical working day usually involves developing clinical protocols, providing strategic and tactical input for design and execution; preparing and presenting study project plans; identifying potential trial vendors; negotiating contracts in collaboration with Finance & Legal Departments; preparing/reviewing all documentation for the Trial Master File required for clinical trials; planning, monitoring and reporting patient accrual; coordinating production, labelling & shipment of clinical supplies; collaborating with inter-departmental study teams; managing all vendor resources and activities to ensure studies are being conducted according to protocol, timelines and budget; participating in on-site regulatory audits; preparing clinical sections of regulatory filings as assigned; participating in Investigators’ meetings and other related events.

I collaborate on the planning and definition of tasks for the corporate projects assigned to me, checking each of the various stages of the project comply with the requirements of the relevant guidelines and regulations. This requires effective collaboration with both suppliers and other company departments, as well as ongoing study of the relevant regulations and guidelines. My role involves issuing and managing quality system documentation: Validation Project Plans, Change Control, qualification and validation documents, and documents for risk analysis/management and procedures.

I carry out the project tasks assigned to me, which mainly involve writing and proofreading quality system documents.
I attend recurring and specific meetings almost every day with internal company departments, suppliers or clients, to define the project tasks or to check on their progress.
For the projects I work on, the internal company departments with which I mainly liaise are the Project Management Office, and the Engineering, Production and Quality Control Departments. I travel offsite, within Italy and abroad.

I manage the industrial costs of our production sites. In particular, I ensure that the resources allocated for product manufacture are managed efficiently to improve the company’s profitability.

Part of the tasks I carry out during the day relate to the monitoring of production processes and factors that impact the “plant model”.
In particular, I analyze the differences between standard costs and actual production costs and try to identify the causes of the discrepancies and propose the appropriate solutions to minimize them.
In addition to this, I evaluate the production processes in a perspective of continuous and efficient improvement.
In this regard, I’m in constant contact with management to define strategic choices and to analyze new investments.
For the operational activities, I liaise with the department managers and their direct collaborators.
In addition to the listed activities, I also manage the analysis of new opportunities, collaborating on this topic with area managers with the aim of identifying better conditions to propose to our potential customers.
Conditions that aim to increase the profitability of the company.