R&d Clinical Trial Support Manager

Sanofi UK

Hyderabad, India
Bachelor's degree in scientific discipline
2 years clinical operations experience
Knowledge of gcp ich fda ema regulations
The Clinical Trial Support Manager supports the clinical study leader in the execution and delivery of clinical studies while ensuring regulatory compliance

Job Summary

  • The Clinical Trial Support Manager supports the clinical study leader in the execution and delivery of clinical studies while ensuring regulatory compliance.
  • Key responsibilities include developing study documents like risk management plans, managing study budgets, and overseeing vendor activities and sample logistics.
  • Candidates must possess a bachelor's degree in a scientific discipline and at least two years of experience in clinical operations with knowledge of GCP and ICH guidelines.

Matching Summary

The Clinical Trial Support Manager supports the clinical study leader in the execution and delivery of clinical studies while ensuring regulatory compliance.

Skills & Requirements

Must-have

  • Bachelor's degree in scientific discipline
  • 2 years clinical operations experience
  • Knowledge of GCP ICH FDA EMA regulations
  • Study Risk Management Plan development
  • Trial Master File maintenance
  • Vendor management and oversight
  • Investigational Medicinal Product management

Nice-to-have

  • Critical thinking and problem-solving mindset
  • Ability to work autonomously
  • Strong written and verbal communication skills
  • Adaptability to new digital tools
  • Experience with centralized monitoring strategies
  • Fluency in English for international meetings

Key Requirements

  • Bachelor's degree (advanced preferred)
  • Minimum 2 years clinical operations experience
  • Proficiency in GCP, ICH, FDA, and EMA regulations
  • English language fluency required

Work Rights

Not specified

Tailored Resume

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