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Standards Specialist Bengaluru India,  


Posted on : 04 April 2017

Project Description

Requisition ID 45967BR Title Standards Specialist Job Category Biostatistics and Data Management Job Description About the departmentClinical Data & Systems Support, Global Development GSC comprises of efficient and qualified team which is mainly responsible for providing diverse functional and system support to execute clinical trials across PDP portfolio. The team has strong understanding of Novo Nordisk Clinical systems and is involved in :  Database set-up, integration of system interfaces at trial level and user access management on clinical systemsSupporting SDTM mapping, SAS programming to enable CDISC submissionsEnd-to-end standardisation of data flow across systemsClinical data tracking reports for trial managementTechnical knowledge in programming and automationRepresentation in control of standards foras, international study group meetings etc.,All in all it s a Dynamic, Diverse and Vibrant unit committed to ClinOps mission of We unite People, Performance, and Process together  team with a fall-back infrastructure of good clinical and technical knowledge.The position Ensure design, set-up of study database for clinical trials are aligned across trials within projectMapping of clinical data and metadata from source system(s) to CDW.Support system releases.Coordinate tasks related to SDTM Programmer activities dealing with both internal and external resources.Share better practices and use of standards.Provide Business support.Give input to maintenance of data model.Facilitate implementation of business processes introduced by the systems supported by CS&DM.Maintain and ensure consistency in communication with teams on standards adherence.Promote knowledge exchange for continuous improvement and quality mindset with focus on compliance QualificationsM.Sc / B.Sc in Life Science or comparable degree in computer science, Information Technology clinical information management or equivalent qualifications. Minimum 7-8 years of experience in pharmaceutical industry and preferably 6 years within clinical data management systemsExpert knowledge on CDISC concepts & deliverablesExpert knowledge on end to end clinical data management activitiesExpert knowledge of computer systems and ITSound knowledge with analysis and design of business processes and functional design within the area of drug developmentKnowledge of validation of computer systemsExtensive experience with collaboration across professional and regional bordersExperience with communication and presentationsExperience in supervision and mentoringRegular participation in conferences/workshopsExperience with project management and stakeholder managementIn-depth knowledge of drug development and basic medical terminologyProfound knowledge of GxP and guidelines within drug developmentAdvanced knowledge of relational database systems and data models. Working at Novo NordiskAt 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 developmentContact (optional)Gururaj BR (BRGA)Deadline (optional)   State/Provinces Karnataka Position Location Bangalore Full Time or Part Time Full Time

Locations

India Bangalore

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