Novo Nordisk is hiring for the position of Clinical Documentation Associate in Bangalore, India. The position requires the handling of paper documents, data entry, and support for submission deliverables at the project level. The ideal candidate will have a bachelor’s degree in life sciences or a related field, strong documentation and stakeholder management skills, fluency in English, and technical proficiency in MS Office
Clinical Documentation Associate
Category: Clinical Development and Medical
Location: Bangalore, Karnataka, IN
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 most efficiently? Do you have an innovative mindset to drive change in a future-ready environment? Are you the 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 teams of professionals who are mainly responsible for providing functional and system support to execute clinical trials across The product Development Plan portfolio. The team has a strong understanding of Clinical Systems & interfaces with the nd-to-start mindset on standardization of data flow across systems, Electronic Case Report Form (ECRF) development using Central Designer, and knowledge of clinical Data Interchange Standards Consortium (CDISC) concepts annotated Case Report Form (CRF, 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.
As a Clinical Documentation Associate, you will be responsible for Ensuring the handling of paper documents such as CRFs, Data Clarification Forms (CRF), and General Agreement Forms (GAF) and Monitor Initiated Discrepancy Forms (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 the 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 as part of the SDTM package. (a CRF, 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 Data Management System (CDMS) per trial/study timelines with an acceptable level of quality.
- Bachelor’s degree preferably in Life Science or comparable degree in computer science, Information Technology clinical information management, or equivalent qualification.
- 0-1 year of data entry experience preferably in clinical database systems.
- Strong Documentation and stakeholder management skills.
- Fluency in written/spoken English and good presentation skills.
- Highly proactive and able to take initiative & 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 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 in 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 the communities we operate in. Together, we’re life-changing