R&D
Where your curiosity drives the
miracles of
science

We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

About us

At Sanofi, we chase the miracles of science to improve people’s lives. All our decisions are taken with our most important stakeholder in mind – the patients.

Having a rich history of innovation that dates back over 100 years, Sanofi more than ever stays true to its commitment to transform the practice of medicine by providing potentially life-changing treatments and the protection of life-saving vaccines to millions of people. This history includes the first treatments for many rare diseases and the establishment of standards of care in diabetes and cardiovascular disease. Sanofi’s commitment to public health has helped protect hundreds of millions of people from influenza every year for decades and pushed polio to the brink of eradication, while its scientific vision has led to breakthrough innovations in the treatment of inflammatory diseases.

~ 43.07Bn€ Net Sales FY23

~ 90 countries

~ 91K employees

~ 59 manufacturing sites

~ 20 R&D sites

The Senior Study Data Manager II (Sr. SDM II) 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 (L-DM) 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 resolution.

 Assuming the plannification of all data management activities, considering the overall study timelines and ensure DM activities are conducted as planned.

 Leading 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 deliverables.

 Accountable 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 function.

 Defining and implementing the study data cleaning and validation strategy integrating risk based approach.

 Involved, as Contributor or Leader, according to the defined processes, in protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, data surveillance and other review activities during the conduct of study.

 Coordinating, in collaboration with vendor external data activities : load, 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 procedures.

 Managing service providers (CROs) independently on data management activities and maintains a good working relationship with vendor. Reviews vendor proposal and contract for inclusion of appropriate scope of work, pricing and agreed services. Performs assessment of vendor performance trends and service risks. Meets regularly with vendor representative to implement mitigation actions. Obtains appropriate approval for scope of work and budget update. Reviews and approves vendor invoices based on the contract. Ensures all vendor contract related documents are processed on-time.

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Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com