# Experienced Clinical Data Management Specialist

5 days ago


Solapur, Maharashtra, India beBeeClinicalDataManagement Full time ₹ 15,00,000 - ₹ 20,00,000
Senior Clinical Data Manager

We are seeking an experienced professional to oversee the clinical data management process for multiple projects, ensuring timely delivery of project objectives.

The ideal candidate will have a strong background in clinical trial/data management and data operations, with a minimum of 10-15 years of experience.

  • 10-15 years of experience in clinical trial/data management and data operations.
  • Minimum 4-5 years of people management (preferred) 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.

Key Responsibilities:

  1. Develop and maintain CTMS configurations, ensuring compliance with regulatory requirements.
  2. Lead cross-functional teams to deliver high-quality clinical data management services.
  3. Collaborate with stakeholders to ensure seamless integration of data management processes.

Requirements:

  • CTMS configuration and administration skills.
  • Deep knowledge of EDC platforms and system 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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