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

About the role

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.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!