La vocation de Sanofi est d’accompagner celles et ceux confrontés à des difficultés de santé. Entreprise biopharmaceutique mondiale spécialisée dans la santé humaine, nous prévenons les maladies avec nos vaccins et proposons des traitements innovants. Nous accompagnons tant ceux qui sont atteints de maladies rares, que les millions de personnes souffrant d’une maladie chronique. Sanofi et ses plus de 100 000 collaborateurs dans 100 pays transforment l’innovation scientifique en solutions de santé partout dans le monde. Sanofi, Empowering Life, donner toute sa force à la vie. Chez Sanofi, la diversité et l’inclusion sont au cœur de notre fonctionnement et sont intégrées à nos Valeurs fondamentales. Nous sommes conscients que pour exploiter véritablement la richesse que la diversité nous apporte, nous devons faire preuve d’inclusion et créer un environnement de travail où ces différences peuvent s’épanouir et être développées pour améliorer le quotidien de nos collègues, patients et clients. Nous respectons et valorisons la diversité de nos collaborateurs, leurs parcours et leurs expériences dans un objectif d’égalité des chances pour tous.
Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail. Join Sanofi as a Senior Clinical Data Manager in Montpellier (France). We are a diverse, global health-care company with an expanding early-stage pipeline. We are seeking individuals who share the same sense of urgency in developing our medicines and supporting patients. As part of this growing international team, you will be able to influence the future of how we conduct our early clinical studies and be a part of a rapidly growing part of the organization. KEY ACCOUNTABILITES The Senior Study Data Manager is responsible for leading and coordinating the end-to-end quality deliverables of data management activities for clinical trial including study set-up, conduct and close-out, complying with GCP and applicable regulatory guidance. Ensure activities are completed according to agreed standards and timelines; serve as representative in the study team; provide comprehensive data management expertise and support to team members; coordinate cross functional teams to ensure the flawless conduct of a clinical trial. This includes Assuming Lead Data Manager role and autonomously acting as one of study team core member; liaises directly with internal customers (Global Study Manager, Study Medical Manager, Statistician, Risk Based Monitoring, Pharmacovigilance, Quality, etc.) to lead all data management activities for assigned study, discuss timelines, and provide study Data management reporting. Proposes solutions for data management issues that arise during the conduct of a study and monitor until resolutionAssuming the planification of all data management activities, considering the overall study timelines and ensure DM activities are conducted as plannedLeading and coordinating internal DM delivery team (Database Developers, Data Management Programmers and Data Management Specialists) assigned on the study, working as a mentor for new Data Managers and accountable for the quality of data management deliverablesAccountable for the DM study deliverables, such as CRFs, CRF Completion Instructions, Centralized Monitoring Plan, Data Management Plan, Data Validation Specifications, Data Review Listings/Reports as per company standards and protocol requirements. Assures that data management standards are followed. Manages study document archiving in eTMF according to eTMF guidance. Participates in Investigator Meetings and other outside meetings if required. Maintains knowledge of current regulations and technologies related to the data management functionDefining and implementing the study data cleaning and validation strategy integrating risk-based approachInvolved, as Contributor or Leader, according to the defined processes, in protocol review, Study Risk Management Plan, Data Validation, Safety Case reconciliation, deviation review, data review, clinical case review and other review activities during the conduct of studyCoordinating, in collaboration with vendor external data activities: Defining File Transfer Specifications, data loading/integration activities and reconciliation activities, including External Lab data, eCOA, IRT integration etc.Participating in the implementation of department initiatives. Implements and oversees processes and coordinates activities in conjunction with the internal team and Team Leader. Continually evaluates DM processes and applications for improvements. Participates in working groups to develop and implement new proceduresManaging service providers (CROs) independently on data management activities and maintains a good working relationship with vendor PROFILE Knowledge and Skills Strong project management skills. Anticipates problems, issues, and delays, and proactively works to minimize the impact. Learns quickly when facing new problems. Uses rigorous, objective logic and methods to solve difficult problems with effective solutions. Able to identify risks and propose mitigation plansStrong leadership behaviors; manages effectively with study team and departmental associates. Establishes rapport and collaborates inside and outside the company. Demonstrates flexibility through effective negotiationsSolid clinical trial development process. Solid understanding of Data Management scope and objectivesUnderstanding of relevant regulatory guidelines, GCP and industry standards and practices regarding data managementSolid Clinical Data Management System experience (RAVE is highly preferred) and understanding of database/programming concepts. Expertise in the usage of Data Management applications and database/file structures. Understands the rationale or is able to identify discrepancies by using query languages, such as SQL. Able to acquire and apply new technical skillsFollows through with all tasks and ensures high quality results. Set clear assignments as well as clear objectives and measures. Monitor process, progress, and results. Consistently meets deadlines according to accepted levels of quality. Pays attention to detailsAutonomously works as Lead DM role with minimal supervision and be capable of participating in transversal activities. Good team playerVendor management experience and good client facing skills are preferredGood interpersonal and communication skillsStrong English skills (both verbal and written) Formal Education and Experience Required Bachelor's degree or above, preferably in a life science or mathematics-related area (e.g., computer sciences)5+ years of experience in clinical data management in the pharmaceutical industry (or equivalent) is required2+ years of project management experience in data management is required Knowledge and Skills Desirable but Not Essential Experience and medical knowledge in relevant therapeutic areaSDTM Basics knowledgeSAS SQL knowledge