BSc, MSc Life Sciences Job Novo Nordisk – Clinical Data Facilitator Vacancy

BSc MSc Life Sciences Job Novo Nordisk – Clinical Data Facilitator Vacancy

BSc MSc Life Sciences Job Novo Nordisk – Clinical Data Facilitator Vacancy. Check out the Clinical Data at Novo Nordisk. Interested and eligible candidates check out all the details given the same below

Job position: Clinical Data Facilitator

Job Location: Bangalore, India

Job category: Clinical Development and Medical

Department: Data Systems & Automation, Bangalore Global Development GBS (DSA,BGD)

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 Facilitator” with us. “Apply Now” At Novo Nordisk, we assure you will experience the best.

About the Department 

Data Systems & Automation (DSA), Data Management, Bengaluru 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 standardization of data-flow across systems

, Electronic Case Report Form (ECRF) development using Central Designer and knowledge 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 Facilitator, you will be responsible for supporting end users and must act independently following the strategic objectives of the standard governance bodies and the company in general. Take ownership on trials assigned by project team to ensure standardization and to a large extent, be performed in accordance with SOPs, policies, and the Novo Nordisk Way.

• Responsible for site user access management on different DM systems (EDC and   eCOA). Configuration settings in User Management tool (UMT).
• Perform compilation of sample (e)CRF and completed (e)CRFs, appendix of Clinical Trial Report (CTR) and Non-interventional Study Report (NSR) for clinical trial and archival in EDMS.
• Support (e)CRFs preparation for submission deliverables at the project level to make them eCTD compliant.
• Perform activities related to submission readiness of PDF files part of SDTM package (aCRF, cSDRG etc)
• Responsible for coordinating the changes in clinical system and interfaces (EDC, IWRS, ARGUS).
• Drive UAT process for Study build trials and handle trial related UAT documentation.

Experience:

• Masters / Bachelor’s degree in Life Science or comparable degree in Computer science, Information Technology Clinical Information Management or equivalent qualifications.
• 2 plus years within clinical data management systems, experience in Project management, Vendor Management, System Management, or related areas.
• Knowledge of computer systems and IT.
• Excellent Communication and Presentations skills.
• Experience with project management
• Knowledge of GxP and guidelines within drug development.
• Lives up to NN values: accountable, ambitious, responsible, and engaged with stakeholders, open & honest and ready for change.
• Quality mind-set and strong analytical skills
• Ability to bridge between different functional areas

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:

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

Deadline : 

• Apply on or before: 6th September 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.

APPLY ONLINE

Possible interview questions may be asked for Clinical Data at Novo Nordisk

1. Can you explain your experience in handling and managing clinical data? Answer: Certainly. I have been responsible for collecting, organizing, and ensuring the accuracy and integrity of clinical trial data. This involved working closely with cross-functional teams, maintaining data quality, resolving discrepancies, and ensuring data compliance with regulatory standards.

2. How do you ensure data quality and accuracy in a clinical trial setting. Answer: I have a systematic approach to data quality. I verify data entries for completeness and consistency, perform regular checks, and collaborate with the clinical team to resolve any discrepancies. This ensures that the data is reliable for analysis and regulatory submission.

3. How do you handle tight deadlines and unexpected challenges in clinical data management? Answer: In such situations, I prioritize tasks, communicate effectively with the team, and focus on critical data aspects. I have experience in adapting to changes swiftly while maintaining data accuracy and compliance, even under pressure.

4. Can you describe your familiarity with regulatory guidelines such as ICH GCP? Answer: I am well-versed in international regulatory guidelines, including ICH GCP. I understand the importance of maintaining data integrity, patient confidentiality, and ensuring that the trial adheres to ethical and regulatory standards throughout the data collection process.

5. How do you approach data privacy and confidentiality in clinical trials? Answer: Data privacy is crucial in clinical trials. I follow strict protocols to handle patient information confidentially, using secure systems and maintaining compliance with relevant data protection regulations such as GDPR and HIPAA.

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