Lead Data Manager

2 days ago

Ghaziabad, Uttar Pradesh, India beBeeClinicalDataManager Full time ₹ 15,00,000 - ₹ 25,00,000

Key Responsibilities:

  • Leads data management and operations for clinical trials with 10-15 years of experience.
  • Supervises a team of professionals with proven leadership skills, utilizing strong analytical and problem-solving abilities.
  • Configures and administers CTMS platforms, including CRIO, RT CTMS, and Veeva Vault CTMS.
  • Maintains EDC systems and ensures compliance with regulatory requirements, such as HIPAA, FDA, EMA, and ICH-GCP.

Requirements:

  • Bachelor's degree in Computer Science, Information Technology, or related field.
  • Strong background in EDC systems management and clinical data operations, with expertise in electronic system validation and 21 CFR Part 11 compliance.
  • Experience working in pharmaceutical, biotechnology, or CRO environments across multiple therapeutic areas.

Tech Requirements:

  • Deep knowledge of EDC platforms and system integrations, with proficiency in software development and technical project management.
  • CTMS configuration and administration skills, with experience in implementing and maintaining complex systems.
  • Electronic systems validation and 21 CFR Part 11 compliance, ensuring accuracy and reliability in data management.

About the Opportunity:

This is a challenging and rewarding role that offers the opportunity to work with a leading technology services provider, utilizing expertise and creativity to deliver innovative solutions to clients.

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