Senior Data Management Professional

4 hours ago

Amrāvati, Maharashtra, India beBeeClinicalData Full time ₹ 1,00,00,000 - ₹ 1,60,00,000

Job Title: Senior Data Management Professional

This is a senior-level role responsible for overseeing the collection, cleaning, and analysis of clinical data from multiple sources. The ideal candidate will have extensive experience in clinical trial/data management and data operations.

Key Responsibilities:

  • Data Management: Oversee the collection, cleaning, and analysis of clinical data from multiple sources.
  • CTMS Administration: Configure and administer CTMS platforms, including CRIO, RT CTMS, Veeva Vault CTMS, and similar systems.
  • EDC Systems Management: Manage EDC systems, ensuring compliance with regulatory requirements and 21 CFR Part 11.
  • Team Leadership: Lead a team of data managers, providing guidance and supervision to ensure high-quality deliverables.
  • Cross-Functional Collaboration: Collaborate with cross-functional teams, including project management, research and development, and quality assurance.

Requirements:

  • 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, EDC systems management, and clinical data operations.

Technical Expertise:

  • CTMS Configuration and Administration: Skills, including knowledge in CRIO.
  • EDC Platforms and System Integrations: Deep knowledge.
  • Regulatory Requirements: Strong understanding of HIPAA, FDA, EMA, ICH-GCP.
  • Electronic Systems Validation: Experience with 21 CFR Part 11 compliance.

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