We are seeking an experienced Local Trial Manager based in Italy (Milan area preferred) to work as an integral part of our pharma client’s global study team. The key function of the Local Trial Manager is to provide operational country oversight and monitor progress of local activities of global studies by project managing a clinical team at a country level.
As a Local Trial Manager, you will be dedicated to one of our global pharmaceutical clients, a company that values performance, recognises merit and has a high focus on quality. This environment encourages innovation, individuality and embraces people that want to be a part of it.
Working throughout the lifecycle of the trial, from start-up through to database lock and closure activities, key responsibilities will include:
- To manage the local execution of study activities, leading the local trial team of on-site monitors and Clinical Trial Assistants; providing them with the necessary tools and training to collectively succeed as a team
- To serve as the primary point of contact at a country level and report study progress to key stakeholders
- To lead the feasibility and study start-up process; setting criteria for site selection and managing the site assessment process and proposing sites to the wider global study team
- To provide expert input into, or even independently create key study plans
- To develop and implement the use of local study tools (eg recruitment plans, risk management plans)
- To track the reporting of SAEs
- To maintain and update trial management systems (with the support of a Clinical Trial Assistant)
- To plan and participate in investigator meetings
- To review visit reports for completeness and adherence to the protocol and to identify site issues and trends
- To collaborate with other study team members as well as investigators and other site staff to build strong working relationships
A typical working day may include creating study documents, meeting with your team, sharing your expert local knowledge with other internal collaborates and even involvement with process improvement initiatives at a more global level. You will truly be a local study expert and will be expected to leverage your experience.