Sanofi is a diverse, global health-care company with an expanding early stage oncology pipeline. As such, the team is expanding to focus on and support this pipeline and the unique needs of early stage oncology studies. We are seeking individuals who share the same sense of urgency in developing our medicines and supporting patients. As part of this growing team, the incumbent will be able to influence the future of how we conduct our clinical studies and be a part of a rapidly growing part of the organization.
The Clinical Data Manager is responsible for end-to-end quality deliverable 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, develop and implement data management plans, serve as representative in the study team, provide comprehensive data management expertise and support to team members and coordinate cross functional teams to ensure the flawless conduct of a clinical trial from a data-flow perspective.
Provides DM leadership and expertise as a core member of the Clinical Trial Team and ensures the CTT members are consulted on study decisions related to Data Management. Liaises directly with internal customers (Clinical, Biostatistics, Safety, Quality Assurance, etc.);
In charge of the study deliverable such as CRFs, eCRF completion guidelines, Data Management Plan, Data Validation Specification, Study Risk Management Plan, Data Review Listings/Reports as per company standards. Assures that data management standards are followed. Provides input in Clinical Trial Protocol, Synopsis, Monitoring Plan and other the other study related documents. 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 function;
Participates 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 procedures;
Manages External Vendors on data management activities and maintains a good working relationship with vendor. Performs assessment of vendor performance trends and service risks. Meets regularly with vendor representative to implement mitigation actions.
Education and qualification
Bachelor’s degree or University degree – Preferably in a life science or mathematics-related area (e.g., computer sciences);
Minimum 5 years of Clinical Data Management or equivalent experience in clinical trial industry of which at least 2 years within Oncology, preferably including Phase 1 and Phase 2 studies.
Skills and Knowledge
Knowledge of Clinical Trial Development Processes;
Knowledge of ICH-GCP, Industry standards and practices;
Strong communication and interpersonal skills;
Experience with tools and systems for managing clinical studies (study progress and metric systems, eCRF databases, …);
Experienced with managing multiple external data sources (labs, biomarker, etc.);
Able to work independently but also in a team environment;
Demonstrated problem-solving capabilities and innovative thinking;
Proficiency in Microsoft Office;
Fluent in English (written and spoken).
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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