Data Management Leader

1 day ago

Nagpur, Maharashtra, India beBeeClinical Full time ₹ 15,00,000 - ₹ 25,00,000

Job Description:

The primary role of a senior clinical data manager involves leading and managing clinical trial/data management teams. This includes configuring and administering CTMS platforms, managing EDC systems, and ensuring compliance with regulatory requirements.

  • Responsibilities:
  • Lead and manage clinical trial/data management teams to deliver high-quality results in the pharmaceutical and biotechnology sectors.
  • Configure and administer CTMS platforms such as CRIO, RT CTMS, or Veeva Vault CTMS, adhering to industry standards and regulatory guidelines.
  • Manage electronic data capture (EDC) systems and clinical data operations to maintain data integrity and accuracy.
  • Ensure ongoing compliance with regulatory requirements including HIPAA, FDA, EMA, ICH-GCP, and 21 CFR Part 11.
  • Maintain electronic system validation and compliance with industry regulations.

Requirements:

Candidates for this position should possess extensive experience working with CTMS platforms, strong backgrounds in EDC systems management and clinical data operations, and knowledge of regulatory requirements and industry standards.

Key Requirements Include:

  • Extensive experience with CTMS platforms and their administration.
  • Strong background in EDC systems management and clinical data operations.
  • Experience working in pharmaceutical, biotechnology, or CRO environments across multiple therapeutic areas.
  • Knowledge of regulatory requirements and industry standards.

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