Asssociate Manager - Clinical Data Management

0 years

0 Lacs

Posted:3 weeks ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

  • Preferred 5 plus years of experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
  • Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
  • Experience with all phases of development in one or more therapeutic areas preferred.
  • Ability to handle multiple development programs simultaneously.
  • NDA/CTD Experience preferred.
  • Strong knowledge of data management best practices & technologies as applied to clinical trials.
  • Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
  • Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
  • Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.

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