About the job

Title: Clinical Documentation Associate

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 “Manager” 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 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 Documentation Associate you will be responsible for Ensure handling of paper documents such as CRFs, Data Clarification Form (CRF), General Agreement Form (GAF) and Monitor Initiated Discrepancy Form (MIDF) from receipt until archival as per Novo Nordisk Standard Operating Procedures (SOP) and local requirements. Perform compilation of sample (e)CRF and completed (e)CRFs for inclusion in the appendix of Clinical Trial Report (CTR) and the Non-interventional Study Report (NSR) for clinical trial/study 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.)
• Support EDC/eCOA decommissioning activities and archival of Services Documentation Package (SDP)/Sponsor Archive Package.
• Perform scanning of paper forms such as CRFs, diaries and archiving.
• Perform data entry of clinical trial data collected on paper Case Report Forms (CRF) into Clinical Da-ta Management System (CDMS) per trial/study timelines with acceptable level of quality.

Experience

• Bachelor’s degree preferably in Life Science or comparable degree in computer science, Information Technology clinical information management or equivalent qualification.
• 0-1 year data entry experience preferably on clinical database systems.
• Strong Documentation and stakeholders management skills.
• Fluency in written/spoken English and good presentation skills.
• Highly proactive and able to take initiatives & manage multiple priorities. Self-managed, strong personal drive and ability to engage with colleagues and peers towards delivering excellent performance and results.
• High cultural sensitivity and comfortable working with cross functional people/stakeholders.
• Technical skills: MS PowerPoint, MS Excel and MS Word is a must.

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: 22nd May, 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.