SDTM Programmer

Category:  Clinical Development and Medical
Location: 

Bangalore, Karnataka, IN

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

Data Standards & Outreach under Clinical & Data Science, GBS 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) or 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 Clinical & Data Science 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.

 

  • Masters/ Bachelors in Life Science or comparable degree in Computer Science, Information Technology clinical information management or equivalent qualifications
  • Minimum 2-6 years of experience in pharmaceutical industry and preferably 2 years 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
  • 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

If you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool.

 

Deadline

Apply on or before: 5th July, 2022

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.