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Trivandrum
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Clinical Data Manager I (CDM I)

Closing on:

17/04/2017

Contact email

careers@clinipace.com

Brief description :

The specific job duties of a Clinical Data Manager I may include but are not limited to:

 

  • For specified projects performs start-up activates including:
    • Developing data management guidelines and study documentation
    • Review of CRF design against protocol
    • Review of database setup
  • For specified projects performs some data management activities as detailed below and performs activities in accordance with our SOPs, Good Clinical Practice, ICH Guidelines and study documentation.
    • Study status tracking
    • Data Entry
    • Review of data listings
    • Identification of data issues and query generation
    • Updating of database with query resolutions (on paper studies only)
    • Archiving of critical documents on an ongoing basis
  • Participate in User Acceptance Testing for assigned projects
  • For specified projects performs study finalization activities including:
    • Database close-out
    • Critical item review
    • Quality Control
    • Archiving

Preferred skills

  • Excellent organizational skills
  • Strong written and verbal communication skills
  • Exceptional attention to detail
  • Technology Proficiency including Data Management Systems
  • Study documentation production and maintenance, data processing, data review
  • Knowledge of clinical research including regulatory requirements GCP/ICH
  • Study management activities
  • Data Quality
  • Strong computer skills, including Microsoft Office
  • Good problem-solving skills