.Job title: _ Local Study Manager_- _ Grade: L3_- _ Hiring Manager: Paulina Liceaga_- _ Location Mexico_- _ 60 % Remote working and 30 % of travel expected._- _ Job type: Undefined_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._Main responsibilities:- Early participation to address operational aspects in the study country strategy in partnership with relevant parties to ensure a smooth and fast path to the First Patient In: identifies gaps and initiates risks assessment in processes, vendors services and resources, Lead Country Study Set up to ensure progress according to study timelines with strategic planning, Review and approve the site selection reports and recommend the final list of sites selected for the study to Cluster/CSU Head for final approval, Develop and initiate early recruitment and retention strategy and associated materials at local level in collaboration with respective colleagues- Lead local study management at the country level from operational point of view starting with experience sharing during feasibility process, through end of the study according to global and local study plan: Attends feasibility meeting to collaborate with SEM and MDA to identify most probably successful sites even for feasibility process, Initiates early exchange with Medical Affairs to identify important sites and/or new sites, Participate in the study MDA handover meeting following country allocation, Organize the Local Kick Off Meeting with respective local study team members, Prepare and lead Local Investigators Meeting; Participate in the regional/global Investigator Meeting.
Lead set-up activities to ensure they are within agreed timelines and according to the company standards, ensure SQV and SIV readiness including proper materials, ensure proper site management, revision and closures are done according to plan.
Accounts for the set-up, completion, and adaptations of project management tools at country level (CTMS, Control room )