About the jobOur Team:The 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 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 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 LSM acts on 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 LSM acts as 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 LSM represents the LSM perspective for CSU in organization wide initiatives.Main responsibilities:Participate in the feasibility evaluation of carrying out a study in the country and the investigators selection.Prepare the country´s study budget and prepare investigator´s contracts when requested.Provide the necessary documentation to submit to the ethics committee, to the HA and other regulatory entities.Ensure that sites are initiated and monitored properly.Ensure and supervise that investigator are fully informed of the organization, the study and of local and international regulations.Participate in local international audits and inspections.Train and coordinate the activities of the monitors.Following up the study files, ensuring that all supporting documentation is available.Major Challenges of the PositionTo achieve that investigators maintain optimum quality and performance.To maintain orderly and up to date study documentation.Organize work teams to ensure and effective result.About youExperience: Education: Languages: Advance in English (essential)Pursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status.Watch our and check out our Diversity Equity and Inclusion actions at !Pursue , discover Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at !
