Opening for Associate Standards Supporter @ Novo Nordisk - Bangalore, Karnataka
Mapping of clinical data and metadata from source system(s) to CDW
Review of (e)CRFs and DCM annotation. Special attention should be given to non-standard modules regarding impact on OC and CDW setup
Map data from IMPACT and OC to CDW ensuring consistency and correctness according to the CDW data model. The Global Library in CDW should be used as basis
Request codes/topic codes as needed
Request changes to OC study setup as needed
Ensure that all data on a trial level is mapped and review the mappings by using the relevant UAT reports
Document the annotation from IMPACT/OC to CDW
Maintain and improve database architecture
Setup global mappings as assigned within the mapping team
Maintain documentation for global mappings
Update documentation related to the system as appropriate
Maintain documentation for codes (controlled terminology)
Qualifications
M . Sc / B . Sc in Life Science or comparable degree in computer science, Information Technology clinical information management or equivalent qualifications.
Minimum 0-2 years of experience in pharmaceutical industry and preferably 1 year within clinical data management systems
Expert general knowledge of computer systems and IT
Knowledge of drug development and basic medical terminology
Knowledge of GxP and guidelines within drug development
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development
Deadline
20 May 2015
Click here to apply
Mapping of clinical data and metadata from source system(s) to CDW
Review of (e)CRFs and DCM annotation. Special attention should be given to non-standard modules regarding impact on OC and CDW setup
Map data from IMPACT and OC to CDW ensuring consistency and correctness according to the CDW data model. The Global Library in CDW should be used as basis
Request codes/topic codes as needed
Request changes to OC study setup as needed
Ensure that all data on a trial level is mapped and review the mappings by using the relevant UAT reports
Document the annotation from IMPACT/OC to CDW
Maintain and improve database architecture
Setup global mappings as assigned within the mapping team
Maintain documentation for global mappings
Update documentation related to the system as appropriate
Maintain documentation for codes (controlled terminology)
Qualifications
M . Sc / B . Sc in Life Science or comparable degree in computer science, Information Technology clinical information management or equivalent qualifications.
Minimum 0-2 years of experience in pharmaceutical industry and preferably 1 year within clinical data management systems
Expert general knowledge of computer systems and IT
Knowledge of drug development and basic medical terminology
Knowledge of GxP and guidelines within drug development
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development
Deadline
20 May 2015
Click here to apply
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