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Clinical Operations Lead

2 weeks ago

Morādābād, Uttar Pradesh, India beBeeData Full time ₹ 1,80,00,000 - ₹ 2,20,00,000

We are seeking an experienced Clinical Data Manager to lead our data operations. The ideal candidate will have 10-15 years of experience in clinical trial/data management and data operations, with a strong background in EDC systems management.

Key responsibilities include managing a team of 4-5 people, configuring and administering CTMS systems, ensuring seamless system integrations, and maintaining robust data security practices. Strong communication and analytical skills are necessary for this role, as the successful candidate will need to collaborate with cross-functional teams and interpret complex data sets.

The selected candidate will also be responsible for driving process improvements, identifying areas for efficiency gains, and implementing best-in-class practices. A deep understanding of CTMS platforms (CRIO, RT CTMS, Veeva Vault CTMS, or similar) and regulatory requirements (HIPAA, FDA, EMA, ICH-GCP) is essential. Experience in electronic systems validation and 21 CFR Part 11 compliance is highly valued.

We seek a professional with a passion for delivering high-quality results and streamlining processes. If you have expertise in data operations and a commitment to excellence, we encourage you to apply.

In this role, you will have the opportunity to work collaboratively with cross-functional teams to achieve business objectives. Your expertise in data management and analysis will be instrumental in driving business growth and improving operational efficiency.

  • Demonstrate expertise in clinical trial/data management and data operations
  • Configure and administer CTMS systems to ensure seamless integration
  • Maintain robust data security practices to protect sensitive information
  • Drive process improvements and identify areas for efficiency gains
  • Implement best-in-class practices to improve operational efficiency