Location
Bangalore | India
Job description
Department: Data Systems & Automation, Bangalore Global Development
Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, Raise your hand as there is an exciting opportunity waiting for you as “Clinical Data Programmer” with us. “Apply Now” At Novo Nordisk, we assure you will experience the best.
About the department
Data Systems & Automation, Bangalore Global Development 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, database build development and raw SDTM generation using Data Management Workbench (DMW) and hands-on experience with Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM) mapping, SAS programming, etc., to aid CDISC submission which is a mandate from regulatory authorities.
The position
As a Clinical data programmer, an ideal candidate will be responsible for maintaining system related documentation, facilitate implementation of business processes introduced by the systems supported by DaMaSys (Data Management Systems & Standards). The responsibility will further include ensuring testing is performed, database meets specification requirements before deploying into production and document pass and fail scenarios in a timely manner.
Design, Programming and validate programs to check data accuracy and aid report generation.
Design and set-up of study database for clinical trials on different sources, mapping of metadata and clinical data from source system(s) to DMW (Data Management Workbench)
Generate SDTM (Study Data Tabulation Model) Deliverables. Responsible performing transformation updates in DMW and Create trial in DMW, apply template and set up DMW Inform model. Perform Transformation updates and installation of data models.
Responsible for requirements related to Clinical Data Acquisition Standards Harmonization and Clinical Data Interchange Standards Consortium.
Experience
M.Sc./B.Sc. in Life Science or comparable degree in computer science, information technology, clinical information management or equivalent.
Minimum 3 years of experience within clinical data management.
Good experience on end-to-end clinical data management activities.
Experience with data management tool like DMW, Medidata Rave or similar.
Good knowledge of clinical systems and preferable experience in programming languages (eg: SAS/SQL/R/Python, Jupyter etc).
Requires basic knowledge on Artificial Intelligence & Machine language to be part of automation/innovation initiatives within and across the departments.
Profound knowledge of GxP and guidelines within drug development.
Fluency in written/spoken English and good presentation skills.
Team oriented personality with a high degree of flexibility.
Quality mind-set and strong analytical skills.
Working At Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. 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. From research and development, through to manufacturing, marketing and sales- we're all working to move the needle on patient care.
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 March, 2023
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.
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