Clinical Data Operations Leader

2 days ago


Kottayam, Kerala, India beBeeClinical Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Summary:

This is an exciting opportunity to join a team as a Senior Clinical Data Manager.

  • We are seeking a highly experienced professional with a strong background in clinical data operations and EDC systems management.

Key Responsibilities:

  1. Design, implement, and maintain clinical trial databases and related systems.
  2. Develop and execute strategies for data collection, cleaning, and analysis.
  3. Collaborate with cross-functional teams to ensure compliance with regulatory requirements.

Requirements:

  • Minimum 10-15 years of experience in clinical trial/data management and data operations.
  • Strong supervisory skills with a minimum of 4-5 years of people management experience (preferred).
  • Extensive experience with CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS, or similar).
  • Deep knowledge of EDC platforms and system integrations.

Benefits:

  • Opportunity to work with cutting-edge technologies and innovative approaches to clinical data management.
  • Collaborative and dynamic work environment.

Additional Information:

  • Experience in pharmaceutical, biotechnology, or CRO environment across multiple therapeutic areas.
  • 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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