Within the CIG Team, the Clinical Data Standard Leaders lead the governance coordination of Sanofi Metadata libraries, by developing new opportunities or assessing improvements to be done, in order to deliver better customer value. Each Clinical Data Standard Leader leads his/her functional standard metadata.

　　In addition to the management of the Sanofi functional Data Standard Library, the Clinical Data Standard Leader represents Sanofi in all internal & external networks initiatives (CDISC, TransCelerate Biopharma, Phuse, etc.), monitor actively Health Authorities requirements, and promotes Data Standards knowledge and best practices within Sanofi.

　　At the study level, the Clinical Data Standard Leader supports clinical teams in supervising the review of study-specific metadata based on customer needs and provides effective solutions through regular analysis of information reported from a broad variety of sources.

　　This role is focused on the management of CDISC Standard Controlled Terminologies.

　　Lead Global Metadata governance activities:

　　Use advanced knowledge of specialized/functional area and propose continuous improvements to deliver efficiency gains to ensure the quality, harmonization, and maintenance of Global Sanofi Metadata defined in CIG Clinical Data Standards, based on Industry Standards, to produce Global releases.

　　Provides and maintains roadmaps for all projects related to his/her functional metadata with timelines of tasks, priorities and supervision of metadata activities.

　　Performs and evaluate impact analysis of any change to his/her functional clinical data standards including implementation of new or up versioned industry standards with guidance for implementation when necessary.

　　Contributes to reporting metrics on Global Requests status to key stakeholders by providing accurate status.

　　Ensures that up-to-date processes are in place for the functional metadata teams (Data Collection, SDTM, CT) to allow efficient ways of working.

　　Collaborates with other teams (Lead Office, Data Integration, B&P...etc.) to ensure standard implementation and end to end consistency of Submission Metadata approach within the company.

　　Develops expertise in CDISC and Submission Standards required by Health Authorities with materials and provide trainings on processes developed by CIG.

　　Contributes to CIG transverse Roadmap:

　　Collaborates with other functional Leaders to implement Clinical Data Governance strategies defined within CIG.

　　Identify areas for improvements within CIG related projects and make suggestions for changes and implementation, as appropriate.

　　Participate in the identification, review, evaluation, and implementation of new technologies related to metadata management.

　　Contributes to an effective communication and collaboration between CIG and other functional groups impacted by CIG activities.

　　Supervise support to the clinical teams in organizing review of study-specific metadata with all functional area representatives to ensure compliance with Sanofi Standard metadata strategy defined at Global level.

　　Ensures harmonization of study specificities between studies and promotes when relevant study specificities to Global Libraries

　　Supervise related study-specific support activities, by ensuring study needs are managed in a timely manner, with quality (External Data, eCRF, CT, SDTM)

　　Identification of standard metadata to be developed or updated according to lessons learned / feedback received from CIG Steering Committee, tools leaders, functional governance teams, or any users.

　　Represent CIG and Sanofi in multidisciplinary working groups (internal and external like CDISC and TransCelerate Biopharma).

　　Promote metadata usage / Educate about Industry network / Regulatory requirements on SDTM/CT

　　Knowledge And Skills:

　　Strong leadership and efficient communication skills

　　Ability to negotiate and gain acceptance of others.

　　Project Leadership and ability to coordinate / oversee multiple projects simultaneously.

　　Strong ability to project team collaboration by interacting with internal or external partners in/outside the Department and with their leaders.

　　Experience in clinical metadata governance systems and reporting,

　　Good knowledge of the industry standards management including control and process development, implementation, and maintenance of these standards.

　　Flexible, diplomatic, and work efficiency in a matrix organization.

　　Capability to alert on emerging issues on the right time and communicate on mitigation plans.

　　Having High level CDISC skills and Metadata Governance experiences

　　Good knowledge of current Clinical Metadata Governance processes, Data Management processes & current Sanofi Transversal Clinical Dataflow

　　Being customer-oriented and quality-oriented

　　Self-motivated & results driven with attention to detail and quality while overseeing projects and connecting with cooperating departments; results driven in terms of timelines and quality.

　　Excellent organization skills

　　Ability to work in an international global organization.

　　Good English communication

　　Formal Education And/or Experience Required:

　　Bachelor's degree or above (or equivalent degree) preferable in life sciences or mathematics related area (e.g., computer science) or relevant field.

　　At least 7 years of relevant professional experience in Pharmaceutical Industry, with strong involvement in the "clinical data flow".

　　Knowledge And Skills Desirable but Not Essential:

　　Project management and planning

　　Strong interest for quality and continuous improvement.

　　Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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　　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.