Settore funzionaleRicerca e sviluppo
CLINICAL PROJECT LEADER (APPARTENENTE ALLE CATEGORIE PROTETTE L.68/99)
CONTRACT TYPE: full time
LOCATION: Milan, Italy
Sanofi’s R&D community is made up of scientists, physicians, technicians, product and manufacturing engineers and many others who contribute to our scientific leadership. Our goal is breakthrough innovation that can transform, extend and potentially save lives.
The Clinical Project Leader (CPL) is responsible for the set up and progress of a clinical trial/observational study/special program in his/her own country or in the assigned countries in the South Europe & Italy Cluster, ensuring compliance with Sanofi Group quality standards and regulations in force, the forecasted timelines, milestones and budget.
- Is accountable for set-up and progress of the study according to the company standards and regulation in force and ensures that committed targets and timelines are met at all steps and until study completion;
- Collaborates with the local Medical Advisor and Site Partnership Manager to identify potential investigators;
- Ensures high quality management of the study;
- Leads the monitoring team in the country;
- Ensures liaison with other local team members and with the study team at global study management level;
- Ensures the selection, management and oversight of the Contract Research Organization, in case of subcontracted studies.
To excel in this role, you need to be skilled in:
- Educated to degree level in a science or medical specialty. A post graduate qualification is highly desirable;
- Preferred previous experience as Clinical Project Leader or equivalent role;
- Knowledge of GCP/ICH phase I-IV clinical trials and observational studies;
- Strong Clinical Project Management skills needed to effectively manage large number of trials in different therapeutic areas and in different countries;
- Strong motivation to high performance;
- Knowledge of the current trends in clinical trials risk-based approach and digital technology;
- Deep knowledge of quality issues management and FDA/EMA requirements for inspection readiness;
- Strong leadership and excellent interpersonal and communication skills including a good customer focus mentality;
- High organizational, analytical and planning abilities, proactivity and ability to anticipate and resolve conflicts/issues, reactivity to emergent needs, ability to prioritize, time management;
- Good IT skills, are essential, for planning, tracking, communicating and reporting;
- Strong English skills (verbal and written).