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Clinical Data Programming Lead

  1. Bangalore
2024-110885
  1. ICON Strategic Solutions
  2. Biometrics Portfolio

About the role

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As a Clinical Data Programmer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.


What you will be doing:

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.


You are:

  • Minimum 3-5 years of experience in pharmaceutical industry and preferably 2 years 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 the  departments.
  • 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.


Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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