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Standards Specialist - India  

Company managed [?] Still accepting applications

Posted on : 04 April 2017

Project Description


About the department
  • Clinical 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 our company Clinical systems and is involved in :
  •  Database set-up, integration of system interfaces at trial level and user access management on clinical systems
  • Supporting SDTM mapping, SAS programming to enable CDISC submissions
  • End-to-end standardization of data flow across systems
  • Clinical data tracking reports for trial management
  • Technical knowledge in programming and automation
  • Representation in control of standards foras, international study group meetings etc.,



The position
  •  Ensure design, set-up of study database for clinical trials are aligned across trials within project
  • Mapping of clinical data and metadata from source system(s) to CDW.
  • Support system releases.Coordinate tasks related to OC-CDW mapping/release 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
 


Qualifications
  • M.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 systems
  • Expert knowledge on CDISC concepts & deliverables
  • Expert knowledge on end to end clinical data management activities
  • Expert knowledge of computer systems and IT
  • Sound knowledge with analysis and design of business processes and functional design within the area of drug development
  • Knowledge of validation of computer systems
  • Extensive experience with collaboration across professional and regional borders
  • Experience with communication and presentations
  • Experience in supervision and mentoring
  • Regular participation in conferences/workshops
  • Experience with project management and stakeholder management
  • In-depth knowledge of drug development and basic medical terminology
  • Profound knowledge of GxP and guidelines within drug development
  • Advanced knowledge of relational database systems and data models.
 


Working with Us:
  • 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