Clinical Data - Bengaluru, India - Novo Nordisk

Novo Nordisk

Verified Company

Bengaluru, India

2 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

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

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 standardisation 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 Noninterventional 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 mindset 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

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.