Senior Clinical Data Associate

Precision Medicine Group

Bangalore, India
On-site
Clinical trial data management
Database development and testing
Crf specifications development
Provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision

Job Summary

  • Provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision.
  • Supports the Lead DM as a back-up and/or team member, ensuring continuity, responsiveness, and that tasks are performed in a timely manner.
  • Identifies and troubleshoots operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.

Matching Summary

Provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision.

Skills & Requirements

Must-have

  • Clinical trial data management
  • Database development and testing
  • CRF specifications development
  • Edit check specification
  • Data management documentation
  • Clinical trial data review
  • Medical coding (MedDRA, WHODrug)
  • SAE/AE reconciliation
  • ICH-GCP knowledge

Nice-to-have

  • Continuous improvement
  • Proactive problem solving
  • Independent work planning
  • Team collaboration
  • Professionalism and punctuality

Key Requirements

  • 5+ years experience
  • Bachelors degree or related experience
  • Proficiency in Microsoft Office
  • Basic knowledge of drug development
  • Professional English communication

Work Rights

Not specified

Tailored Resume

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