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Clinical Database Programmer

Clinical Database Programmer

ConfidentialKolkata, Mumbai
9 days ago
Job description

Tools Required

  • Rave
  • Oracle Inform
  • Veeva Studio

Roles and Responsibilities

  • Protocol reading and understanding
  • Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system
  • Setup Core Configurations
  • Implementing the Dynamic rules as per the Sponsor requirements
  • Experienced in writing the Data Validation Specification (DVS)
  • Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation Specification
  • Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC
  • Expertise in performing Technical and Functional Review
  • Incorporate internal feedback and update programs as required
  • Must Have

  • Scientific background : A solid understanding of Clinical Protocol, medical and scientific principles of conducting clinical trials
  • Strong writing and communication skills : The ability to clearly articulate and concisely explain complex information
  • Research and analytical skills : Ability to gather, interpret, and synthesize data into insightful information
  • Attention to detail : Ensuring accuracy and adherence to guidelines such as Protocol, Specification, Library Standards, ICH GCP, etc
  • Project management skills : Managing the document development process and meeting timelines
  • People management skills : Managing the team of highly qualified individuals (applicable for Team Lead role only)
  • Location

  • Gurgaon / Pune
  • Educational Qualifications

  • B.E. / B.Tech – Computer Science-based courses or Circuit Branches
  • M.Sc. / MCA – in the stream of Computer Science
  • B.Sc. / BCA – in the stream of Computer Science
  • Skills Required

    Rave, Oracle Inform, Veeva Studio, eCRF Design, EDC Systems, Core Configuration Setup

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