Clinical Data Programmer-edc

4 weeks ago

Bengaluru, India Novo Nordisk Full time

**Department: Data Systems & Automation, Clinical & Data Science (CDS) GBS**

**About the department**

Data Systems & Automation, Bangalore 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**
- Responsible for design, Programming and validate programs to check data accuracy and aid report generation.
- Responsible for design and set-up of study database for data collection in clinical trials based on protocol needs.
- Create trial in central designer for set up of trial database and activate the database upon approval from relevant stakeholders. Strong understanding of different types of validation checks and proficiency in creating test case scenarios.
- Active participation in sharing better practices on use of standards in alignment with Lead Clinical Data Programmer and Process & Automation Specialist.
- Responsible for Central Designer Programming testing, validation and execution by the defined process. Understanding of Central Designer platform on layout, typography, and other design principles.

**Experience**
- M.Sc./B.Sc. in Life Science or comparable degree in computer science, information technology, clinical information management or equivalent.
- Minimum 3-5 years of experience in pharmaceutical industry and preferably 2 years within clinical data management.
- Good experience on end-to-end clinical data management activities.
- 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**

**Deadline**

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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