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CLINICAL STUDY DIRECTOR
This role is key for medical supervision and medical management of clinical trials proposed or to be performed by the Clinical Science & Operations Platform (CSO) of Sanofi R&D. The Clinical Study Director (CSD) is the medical reference in the clinical study and other clinical activities (clinical part of CTD for registration, feasibility, ...) performed by the CSO. The CSD will provide appropriate medical input and support for all these clinical activities. He/she will provide medical training and medical information to study team(s), Clinical Study Units (CSUs) and investigators. He/she will be deeply involved in the feasibility process. He/she will be accountable for medical review and will collaborate and interact with Pharmacovigilance to review safety data. He/she will interact with Medical Advisors in CRUs or Disease Units), a specialization in a medical area would be requested or at least appreciated.
· Licensed United States Medical Doctor or an International medical graduate who has certification by the Educational Commission for Foreign Medical Graduates (ECFMG).
· 2-3 or more years of Phase 2/3 Clinical Research / Drug Development experience in the pharmaceutical industry.
· Knowledge in ICH, GCP and local regulations
· Fluent in English (writing and speaking)
· Additional Clinical Research and/or Drug Development experience in other therapeutic areas, especially Cardiovascular and Metabolism.
All clinical studies related to projects in clinical development (excluding Clinical & Exploratory Pharmacology studies) and medical investigations (e.g. Registry, survey) for projects in development or for marketed drugs.
KEY INDIVIDUAL ACCOUNTABILITIES
· Medical reference and medical expertise for operational strategy within the CSO for study registries he/she is allocated to
· Medical consultant for projects to be proposed to the CSO
· Medical contact for interaction with physicians responsible for the project or the study at the customer level
· Support with his/her medical knowledge and background a study or a project from
· business negotiation with customers to final product delivery (e.g. study completion or
· project report or publication)
· Conduct the feasibility for study/project with the feasibility manager and other team members (especially Medical Advisors in CSUs)
· Prepare and/or organize and/or participate to Investigator's Meetings, Steering Committees, Data Monitoring Committee meetings (only "open” part of the DMC meetings).
· Prepare and/or approve any documents related to the study and requiring a medical expertise (extended synopsis, protocol, medical training material for study monitoring team and for investigators)
· Provide medical training to study team, CSUs (Medical Advisors, monitoring) and investigators
· Develop interaction with Medical Advisors in CSUs for the best knowledge of the study, compound protocol
· Participate to Investigators meetings
· Provide medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts
· Participate to clinical trial team (and cluster if any) meetings
· Accountable for the medical review of data done by the clinical trial team, the case by case review of safety events reported to GPE and coding of events and drugs
· Provide appropriate medical input for patient recruitment and retention strategy
· Support the CSUs and affiliates to develop network of KOLs and experts and to select National Coordinators or members of Study Committees
· Prepare and provide key medical information to investigators and/experts in respect with communication policies (e.g. study results, DMC advice)
KEY SHARED ACCOUNTABILITIES
· Feasibility results with feasibility managers
· Project/Study deliverables with the Clinical Study Team
· Operational strategy with Project Leader (s)
· Get support from the Unit Management Office to get appropriate medical staff in CSUs and to determine appropriate study budget according to medical considerations
· Collaborate to Adjudication Committee Review including prior patients' data review as needed
· Ensure high quality execution from a medical perspective with support of all functions &
· Quality & Continuous Improvement group
· Ensure appropriate documentation and investigations of safety cases with Global
· Pharmacovigilance and Epidemiology (GPE).
· Ensure high quality of coding with coding officers
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