R&d Clinical Trial Support Manager

Sanofi Genzyme

Hyderabad, India
2 years clinical operations experience
Gcp and ich guidelines knowledge
Study documentation and tmf management
The Clinical Trial Support Manager supports the study leader in executing clinical studies while ensuring regulatory compliance

Job Summary

  • The Clinical Trial Support Manager supports the study leader in executing clinical studies while ensuring regulatory compliance.
  • Key responsibilities include developing study plans, managing budgets, overseeing vendor activities, and maintaining the Trial Master File.
  • The role requires close collaboration with translational medicine teams to manage clinical samples and investigational medicinal products.

Matching Summary

The Clinical Trial Support Manager supports the study leader in executing clinical studies while ensuring regulatory compliance.

Skills & Requirements

Must-have

  • 2 years clinical operations experience
  • GCP and ICH guidelines knowledge
  • Study documentation and TMF management
  • Budget tracking and invoice approval
  • Vendor oversight and management
  • Sample collection and IMP logistics

Nice-to-have

  • Critical thinking and problem-solving mindset
  • Proactive issue escalation and resolution
  • Cross-functional collaboration skills
  • Adaptability to new digital tools
  • Strong written and verbal communication

Key Requirements

  • Bachelor's degree in scientific discipline
  • Minimum 2 years experience in clinical operations
  • Knowledge of FDA and EMA regulations

Work Rights

Not specified

Tailored Resume

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