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Clinical Data Standards Lead

Synthorx

Synthorx

Hyderabad, Telangana, India
Posted on Saturday, June 15, 2024

Job title: Clinical Data Standards Lead

  • Location: IN / Hyderabad


About the job

Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As a member of a CIG (Clinical Information Governance) team, the Clinical Data Standards Lead works transversally with other Clinical Data Standards Leads to develop and maintain the Sanofi Clinical Data Standards libraries based on business needs and in compliance with Industry Standards (CDISC, FDA, PMDA…Etc.) with a focus on end-to-end standards governance process definition (i.e., Global request workflow management, Global release process…etc.).

In addition, the Clinical Data Standards Lead collaborates representing Sanofi in transversal initiatives (such as ACT4P) and external network initiatives (such as CDISC, TransCelerate, PHUSE, etc.). In relation to Data Standards, monitors actively Health Authority requirements, and promotes Data Standards knowledge and best practices within Sanofi. Leads the definition and optimization of CIG governance processes. Actively leads Therapeutic Area Working Groups. Clinical Data Standards Lead will bridge the gaps between global metadata strategy and its adoption within therapeutic areas.


Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Clinical Information Governance team as Clinical Data Standards Lead and you’ll help shape the future of Clinical Data Standards at Sanofi and across our industry.


Main responsibilities:

  • Clinical Data Standards Lead will be responsible and accountable for the governance and management of Data Standards across the functional areas described below:

  • Data Collection (Leads management of metadata for eCRF and External Data collection; CDASH)

  • SDTM Lead (Leads management of metadata mapping from Data Collection to SDTM)

  • Controlled Terminology (Leads management of Standard Controlled Terminologies across all metadata). Technology (Leads the management of User administration, QC Programming, other technical activities). Metadata Standards Analyst (Leads the management of Study specific requests.). The Clinical Data Standards Lead manages a group of Data Standards Analysts specialized on functional areas. Use advanced knowledge of a functional area to propose continuous improvements to deliver efficiency gains to ensure the quality, harmonization, and maintenance of Global Sanofi Metadata.

  • Maintains KPIs and process related documents. Performs and evaluate impact analysis of any change to his/her functional clinical data standards including implementation of new or up versioned industry standards and provides guidance for implementation when necessary. Collaborates with other functional leads and teams (Lead Office, Data Integration, B&P…etc.) to ensure standard implementation and end to end consistency of Metadata.

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

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

About you

  • Experience: Strong relevant professional experience in Pharmaceutical Industry, with strong involvement in the “clinical data flow”, specialized in Data Standards Management.

  • Advanced knowledge of industry data standards and practices (e.g., CDISC/CDASH/SDTM). Having High level CDISC skills and Metadata Governance practices. (Preferred CDISC certification in one of more of the models).

  • Familiar with end-to-end clinical data flows and data structures

  • Soft and technical skills: Strong English skills (verbal and written), ability to exchange fluently in a global environment.

  • Efficient communication skills and good organization skills.

  • Ability to negotiate and gain acceptance of others.

  • Ability to coordinate/oversee multiple tasks simultaneously.

  • Project team collaboration by interacting with internal or external partners in/outside the Department and with their leaders.

  • Self-motivated & results driven with attention to detail and quality.

  • Education: Bachelor’s degree or above, preferably in Life Science or related field

  • Languages: Excellent English language knowledge – written and spoken.

Why choose us?

  • Bring the miracles of science to life alongside a supportive, future-focused team.

  • Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

  • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave.


“This role is critical to our team’s success and provides exposure to industry-wide developments of Data Standards. It is an opportunity to become a leader within a network of subject matter experts collaborating to shape the future of Data Standards for Clinical Research.”

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, ability or gender identity.

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