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SDTM Programmer

Category:  Clinical Development and Medical
Location: 

Bangalore, Karnataka, IN

   

SDTM Programmer in Global Development

 

Does your motivation come from challenges and working in a dynamic environment? Is your ambition to create visible results? Are you enthusiastic about understanding the business and bringing attention to key business challenges? Then we might have the right position for you.

 

About the department

Clinical Data & Systems Support, Global Development is one of the most competent and diverse team of professionals who are mainly responsible for providing functional and system support to execute clinical trials across Product Development Plan portfolio. The team has strong understanding of Clinical Systems & interfaces with end-to-start mindset on standardisation of data-flow across systems, Electronic Case Report Form (ECRF) development using Central Designer and hands-on experience with Clinical Data Interchange Standards Consortium (CDISC)concepts annotated Case Report Form (aCRF), Study Data Tabulation Model (SDTM) mapping, SAS programming, Study Data Review Guideline (SDRG) etc., to aid CDISC submission which is a mandate from regulatory authorities. 

 

The position

Your key responsibilities in the job is to design and set-up of study database for clinical trials on different sources, Mapping of metadata and clinical data from source system(s) to CDW (Clinical Data Warehouse)/ Database Management workbench (DMW) and finalize SDTM (Study Data Tabulation Model) deliverables and also review and provide inputs to EDC (Electronic Data Capture) requirements in relation but not limited to protocol, flow chart, SDTM domains etc, and create trial in CDMS (Clinical Data Management System), set up trial database and activate the database in OC (Oracle Clinical) upon approval from relevant stakeholders, Perform and document UAT (User Acceptance testing) for checking the quality of OC database and also prepare and submit the request to Control of Standards group to either deviate from an existing standard or use a trial specific element in alignment with Lead SDTM Programmer. You should always be technically updated and ensure that the newest knowledge is shared with relevant stakeholders including super users in global development on database set-up, SDTM standards, interface integrations including but not limited to EDC-OC, IWRS-OC, ePRO-OC, OC-CDW-SDTM, EDC-DMW.

 

Maintain system related documentation and facilitate implementation of business processes introduced by the systems supported by Data Management Systems & Standards (DaMaSys) and finally share better practices on use of standards in alignment with Lead SDTM Programmer and Standards Specialist.

 

Qualifications

The below knowledge, skills and experience will be required for the position.

 

  • M.Sc. / B.Sc. in Life Science or comparable degree in Computer Science, Information Technology clinical information management or equivalent qualifications
  • Minimum 1-4 years of experience in pharmaceutical industry and preferably minimal 1+ year within clinical data management and hands on experience in CDISC SDTM.
  • Good experience on end to end clinical data management activities.
  • Extensive experience with reporting clinical trials, including statistical data handling, analysis and reporting
  • Extensive experience with validation and documentation of programs
  • Good experience on end to end clinical data management activities.
  • Knowledge with analysis and design of business processes within the area of drug development.
  • Experience with collaboration across professional and regional borders.
  • Experience with communication and presentations.
  • Good project management experience.
  • Profound knowledge of GxP and guidelines within drug development.
  • Experience with clinical database technologies, data models and advanced  programming
  • Regular experience with communication and presentations
  • In-depth knowledge of computer systems and IT
  • Good knowledge of GxP and guidelines within drug development

 

Soft skills:

Lives up to NN values: accountable, ambitious, responsible, and engaged with stakeholders, open and honest and ready for change

 

Working at Novo Nordisk

At Novo Nordisk, we have been changing diabetes since 1923. If you are ready to strengthen our position as an innovative pioneer and respected industry leader, we encourage you to join us to make the most of your talent. In exchange, we offer you the opportunity to work with extraordinary talent globally and benefit from a range of possibilities for professional and personal development. 

 

Contact

For further information, please contact Ekta at eksn@novonordisk.com .

 

Deadline

4th September 2021.

Millions rely on us 

At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.