Lead Clinical Data Operations Specialist

2 days ago

Kanpur, Uttar Pradesh, India beBeeDataManager Full time ₹ 18,00,000 - ₹ 25,00,000
Senior Clinical Data Manager

We are seeking a highly experienced professional to fill the role of Senior Clinical Data Manager at Crescent Tech Services.

Key Responsibilities:

  • Clinical Trial/Data Management: 10-15 years of experience in clinical trial/data management and data operations, ensuring high-quality data collection, management, and analysis.
  • People Management: Minimum 4-5 years of people management (preferred) experience with proven supervisory skills, leading cross-functional teams to achieve project goals.
  • CTMS Administration: Extensive experience with CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS, or similar), configuring and administering systems to optimize clinical trial execution.
  • EDC Systems Management: Strong background in EDC systems management and clinical data operations, ensuring compliance with regulatory requirements.
  • Pharmaceutical/Biotechnology Experience: Experience in pharmaceutical, biotechnology, or CRO environment across multiple therapeutic areas, applying knowledge of clinical trials and data management principles.

Technical Expertise:

  • CTMS Configuration: CTMS configuration and administration skills, with knowledge in CRIO being an advantage.
  • EDC Platforms: Deep knowledge of EDC platforms and system integrations, ensuring seamless data flow and integration.
  • Regulatory Compliance: Strong understanding of regulatory requirements (HIPAA, FDA, EMA, ICH-GCP), ensuring compliance and adherence to industry standards.
  • Electronic Systems Validation: Experience with electronic systems validation and 21 CFR Part 11 compliance, ensuring the accuracy and integrity of clinical data.

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