The Clinical Project Leader (CPL) / Local Study Manager (LSM) is part of the Clinical Study Unit (CSU), and is accountable for the strategic planning & management, and performance of their assigned clinical trials from country allocation within the feasibility process until study closure inclusive archiving at the CSU level including study timelines, study budget, and study conduct in accordance with Sanofi SOPs and ICH/GCP and regulatory guidelines & directives.
This includes the ability to identify and anticipate risks jeopardizing the trial performance and to develop and initiate countermeasures based on proposer planning and regular revision of the plans.
The CPL / LSM is working cross-countries or cross-clusters and covers satellite countries as well.
For studies with no RSM assigned (mono-country studies, EDOO studies in escalation phase, or EDO studies) LSM may assume partially RSM tasks as needed.
The CPL / LSM acts on the country/cluster level as the key strategic interface with internal and external stakeholders to develop, implement, maintain, and improve operational processes to accelerate trial conduct in close collaboration with respective functions within CSU and other departments, e.g., Medical Advisor, Site Engagement Manager, Strategic Start Up Manager, Medical Science Liaisons.
The CPL / LSM acts as a Person of contact within a therapeutic area in terms of study management and conduct and leads a study team through change management efforts and by example.
The CPL / LSM represents the CPL/ LSM perspective for CSU in organization-wide initiatives.
