Clinical Operations Specialist

1 week ago

Alwar, Rajasthan, India beBeeData Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

Job Title: Senior Clinical Data Manager

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Job Summary:

We are seeking a highly experienced Senior Clinical Data Manager to join our organization. The ideal candidate will have a strong background in clinical data operations and management, with a minimum of 10-15 years of experience in the pharmaceutical, biotechnology, or CRO environment.

Key Responsibilities:

  • Manage and oversee clinical trial/data management and data operations teams.
  • Provide technical expertise and guidance on CTMS configuration and administration, EDC platforms, and system integrations.
  • Ensure compliance with regulatory requirements, including HIPAA, FDA, EMA, ICH-GCP, and 21 CFR Part 11.
  • Develop and implement effective data management strategies to ensure data quality and integrity.

Requirements:

  • Minimum 10-15 years of experience in clinical trial/data management and data operations.
  • 4-5 years of people management experience with proven supervisory skills.
  • Extensive experience with CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS, or similar).
  • Strong background in EDC systems management and clinical data operations.
  • Experience in pharmaceutical, biotechnology, or CRO environment across multiple therapeutic areas.

Technical Expertise:

  • CTMS configuration and administration skills.
  • Deep knowledge of EDC platforms and system integrations.
  • Strong understanding of regulatory requirements.
  • Experience with electronic systems validation and 21 CFR Part 11 compliance.

About Us: We offer a competitive compensation package and opportunities for career growth and development.

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