Clinical Data Manager Specialist

5 days ago

Cochin, Kerala, India beBeeData Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Role:

A senior clinical data manager oversees the entire lifecycle of clinical trial data, ensuring accuracy and compliance with regulatory requirements.

Key Responsibilities:

  • Manage a team to process large volumes of clinical trial data
  • Collaborate with cross-functional teams to develop data management strategies
  • Design CTMS platforms for project-specific needs
  • Ensure EDC system integrity through regular validation and maintenance tasks
  • Maintain knowledge of regulatory requirements and ensure compliance

Requirements:

  • 10-15 years of experience in clinical trials/data management and operations
  • Minimum 4-5 years of people management experience with supervisory skills
  • Extensive experience with CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS)
  • Strong background in EDC systems management and clinical data operations

Technical Expertise:

  • CTMS configuration and administration skills
  • Deep knowledge of EDC platforms and integrations
  • Strong understanding of regulatory requirements (HIPAA, FDA, EMA, ICH-GCP)
  • Experience with electronic systems validation and 21 CFR Part 11 compliance

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