Life Sciences Clinical Data

Life Sciences Clinical Data Programmer Job at Novo Nordisk, Apply Online

Life Sciences Clinical Data Programmer Job at Novo Nordisk, Apply Online. Life Sciences Jobs. Life Sciences Clinical Data Programmer Vacancy. Interested and eligible applicants can check out all of the details on the same below

Hey there, looking for assistance on the possible interview questions and answers for the role of Clinical Data Programmer at Novo Nordisk, then check them below

Clinical Data Programmer-EDC

Category: Clinical Development and Medical

Location: Bangalore, Karnataka, IN

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

Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment.

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

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.

  • 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, 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 31st May 2023.

APPLY ONLINE

Hey there, looking for assistance on the possible interview questions and answers for the role of Clinical Data Programmer at Novo Nordisk, then check them below

  1. Can you describe your experience and expertise in clinical data management within the pharmaceutical industry?
    • Answer: I have been working in the pharmaceutical industry for the past 3-5 years, with a specific focus on clinical data management. During this time, I have gained extensive experience in end-to-end clinical data management activities, including database design, programming, data validation, and report generation. I am proficient in using programming languages such as SAS, SQL, and Python for data analysis and manipulation. I have a deep understanding of GxP guidelines and regulatory requirements within drug development.
  2. How familiar are you with clinical systems and data management standards, such as CDISC and Electronic Case Report Form (eCRF) development?
    • Answer: I have a strong knowledge of clinical systems and their integration within the data management process. I have hands-on experience in utilizing CDISC standards, including annotated Case Report Form (aCRF) creation, Study Data Tabulation Model (SDTM) mapping, and Study Data Review Guideline (SDRG) preparation for CDISC submission. I am also well-versed in using tools like Central Designer for eCRF development and have a solid understanding of different types of validation checks and test case scenarios.
  3. How do you ensure data accuracy and quality in clinical trials? Can you describe your approach to programming and validating programs for data accuracy?
    • Answer: Ensuring data accuracy and quality is a critical aspect of clinical data management. When programming and validating programs, I follow a systematic approach. First, I carefully design programs that align with the data collection needs specified in the trial protocol. I then conduct thorough testing to verify data accuracy and validate the programs. I document pass and fail scenarios in a timely manner and make necessary adjustments to ensure the database meets specification requirements before deployment into production.
  4. Are you familiar with automation and innovation initiatives in clinical data management, particularly in the context of Artificial Intelligence (AI) and Machine Learning (ML)?
    • Answer: Yes, I have a basic knowledge of AI and ML and understand their potential applications in automation and innovation within clinical data management. I am aware of the importance of leveraging these technologies to improve efficiency and accuracy in data processing, analysis, and decision-making. I am eager to contribute to automation initiatives and explore ways to incorporate AI and ML in data management processes to drive continuous improvement.
  5. Can you provide an example of a situation where you had to collaborate with key stakeholders to implement new business processes related to clinical data management systems?
    • Answer: In a previous role, we introduced a new clinical data management system to streamline data collection and enhance efficiency. As part of the implementation, I collaborated closely with key stakeholders, including the Clinical Data Programmer Lead and Process & Automation Specialist. Together, we analyzed the existing processes, identified areas for improvement, and designed a new workflow that aligned with the capabilities of the system. Through effective communication, teamwork, and training sessions, we successfully implemented the new business processes and achieved the desired outcomes.

Note: The answers provided are for reference purposes and can be customized based on the individual’s actual experience and qualifications.

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