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Senior SDTM Programmer

Category:  Clinical Development and Medical
Location: 

Bangalore, Karnataka, IN

   

We are looking for a Senior SDTM Programmer in Global Development unit based out of Global Business Service (GBS), Bangalore, India. You can look forward to an exciting job driving different projects and engaging with multiple stakeholders at the global level.

The position

Your key responsibilities in the job will be to design and set-up of study database for clinical trials and do the mapping of clinical data and metadata from source system(s) to Clinical Data Warehouse (CDW) and finalize SDTM deliverables. You will share better practices on use of standards in alignment with Lead SDTM Programmer and Standards Specialist and provide Business support. You will have to maintain system related documentation and facilitate implementation of business processes introduced by the systems supported by Clinical Systems & Data Management (CS&DM). At times if required you will have to support Clinical Data Interchange Standards Consortium (CDISC) Current Solution support.

Senior SDTM Programmer is expected to be responsible to collaborate on agreeing to timeline for EDC build and design process, Provide study level, end to end program/project management for EDC activities using EDC build tool, build and configure the eCRFs including: eCRFs (Forms), eCRFs for external data, standards, rules (edit checks) and the underlying study structure to support the NN provided protocol, generate case report forms (eCRF) for review and approval of eCRFs, Clinical database development activities, including protocol review, CRF/eCRF design, database discrepancy criteria, database development and testing, Peer Review (if required), IVRS error log testing, EDT file updates, LNMT mapping finally facilitate database lock and executes change requests.

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 4-9 years of experience in pharmaceutical industry and preferably 4 years within clinical data management and hands on experience in Central Design
  • Advanced knowledge of computer systems
  • Expert knowledge with analysis and design of business processes and functional design within the area of drug development
  • Knowledge of validation of computer systems
  • Extensive experience with collaboration across professional and regional borders
  • Experience with communication and presentations
  • Experience in supervision and mentoring
  • Regular participation in conferences/workshops
  • Demonstrated experience with project management
  • Profound knowledge of GxP and other guidelines within drug development


 

The Senior SDTM Programmer must be a consistent strong performer, demonstrated by having a track record of completed projects and orchestrated support.

A variety of tasks must be performed simultaneously; the tools used are technically advanced; and, often, only general guidelines are available. Consequently, a great deal of knowledge is demanded. Additionally, sound understanding of related tasks is necessary.

Owing to regulatory requests, newly discovered clinical implications and business opportunities, the priorities of activities change frequently. The Senior SDTM programmer has a direct business impact on the critical time used for getting new drugs to the market and the quality of the work performed. Thus the tasks carried out strongly affects the business results of Novo Nordisk. The pressure and stress of the position can be considerable and requires stable and flexible staff.

General Skills

 

  • Fluency in written and spoken English
  • Ability to work in a diverse multi-cultural environment
  • Committed and responsible
  • Proactive and solution oriented approach to challenges
  • Team oriented personality with a high degree of flexibility
  • Planning/Co-ordinating abilities
  • Quality mind-set and strong analytical skills


 

Soft Skills

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

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.

Working at Novo Nordisk

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. We create value by putting patients first. Working here is not just a way to make a living, but a way to make a difference.

Contact

To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions). Internal candidates are kindly requested to inform their line Manager before applying.

Deadline

20 December 2021.

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.