Do you have a strong background in clinical trial conduct and data standards development within the pharmaceutical industry? Are you passionate about leading teams, developing experts and about data? Do you know how to broaden awareness of your department’s responsibilities and have a gut feeling on when to promote the achievements and cool releases? If yes, we want you to lead our SDTM Standards department! Apply today for a life-changing career. The position As a Leader for the SDTM (Study Data Tabulation Model) Standards department, you will have the following key responsibilities:
Ensure continued development of Clinical Data Standards in collaboration with Clinical Data Operations & Insights (CDOI), Biostatistics, Trial Management, Medical & Science, Clinical Pharmacology and Global Safety Functionally responsible for the programming framework utilised to transform all clinical data into the SDTM data model, Define-XML and Study Data Reviewers Guides on all clinical trials and submissions in Novo Nordisk Global responsibility enabling the SDTM Programming departments in delivering data in the SDTM data model on all Clinical Trials and submissions in collaboration with the Standard Developer departments In collaboration with the leadership team: Enforce global Clinical Data Standards in line with global regulatory requirements Compliance with global data standard requirements is a prerequisite for Novo Nordisk to submi...