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Clinical Data Programmer

3 months ago

Bangalore Metropolitan Area, India ICON Strategic Solutions Full time
  • Design and set-up of study database for data collection in clinical trials based on protocol needs
  • Set up of models and performing transformation updates in DMW
  • Mapping of metadata and clinical data from source system(s) to DMW (Data Management Workbench)/ CDW (Clinical Data Warehouse) and generate SDTM (Study Data Tabulation Model) deliverables.
  • Active participation in sharing better practices on use of standards in alignment with Lead Clinical
  • Data Programmer and Process & Automation Specialist.
  • Maintain system related documentation.
  • Facilitate implementation of business processes introduced by the systems supported by DaMaSys (Data Management Systems & Standards).
  • Ensure testing is performed and database meets specification requirements before deployed into production and document pass and fail scenarios in a timely manner.
  • Design, Programming and validate programs to check data accuracy and aid report generation.


Experience Required:

  • Minimum 3-5 years of experience in pharmaceutical industry and preferably 2years within clinical data management and hands on experience in CDASH, CDISC requirements.
  • Good experience on end-to-end clinical data management activities.
  • Good knowledge of clinical systems and preferable experience in programming languages (eg: SAS/SQL/R/Python, Jupyter etc). Requires basic knowledge on AI & ML to be part automation/innovation initiatives within and across thedepartments.
  • Knowledge with analysis and design of business processes within the area of drug development.
  • Experience with collaboration across professional and regional borders.
  • Good project management experience.
  • Profound knowledge of GxP and guidelines within drug development.
  • Fluency in written/spoken English and good presentation skills
  • Team oriented personality with a high degree of flexibility
  • Quality mind-set and strong analytical skills.


Education:

M.Sc / B.Sc in Life Science or comparable degree in computer science, Information Technology clinical information management or equivalent qualifications.