Clinical Data Management Specialist

2 weeks ago


Delhi, Delhi, India Abbott Full time

Clinical Data Management Role


A talented and experienced Clinical Data Management Specialist to support the development and delivery of clinical trials. The ideal candidate will have a strong background in data management and a proven track record of delivering high-quality data management plans, data review guidelines, and database validation protocols.



Key Responsibilities:

  • Attend Clinical Project Team meetings to gather business need requirements and translate to technical requirements
  • Partner with other shared service functions such as Safety, Core Lab, etc. to gather business need requirements and translate to technical requirements
  • Identify, analyze, propose solutions, and effectively resolve complex data issues by exercising appropriate judgment and collaborating with the clinical project team members and other shared service functions
  • Train database End Users (internal and external users) on the database and/or maintain automated database training system
  • Capture and maintain Database and Systems training records
  • Assist in FDA and Quality audits that involve Clinical Database and Data Management


Requirements:

  • Proven experience in clinical data management
  • Strong understanding of data management standards and best practices
  • Ability to work collaboratively with cross-functional teams
  • Excellent communication and problem-solving skills
  • Experience with database management tools and technologies



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