Senior Clinical Operations Manager

13 hours ago

Chennai, Tamil Nadu, India beBeeClinicalDataManager Full time ₹ 1,41,12,000 - ₹ 2,41,68,000

Job Title: Clinical Data Management Specialist

About the Role:

The successful candidate will have a strong background in clinical data management and operations, with extensive experience in CTMS platforms and EDC systems. They will be responsible for overseeing and maintaining large datasets, ensuring compliance with regulatory requirements, and leading teams of data managers.

Key Responsibilities:

  • Manage and maintain large clinical trial datasets, including data cleaning, validation, and reporting.
  • Configure and administer CTMS platforms, ensuring seamless integration with EDC systems.
  • Develop and implement data management strategies to ensure compliance with regulatory requirements (HIPAA, FDA, EMA, ICH-GCP).
  • Lead and manage teams of data managers, providing guidance and training on data management best practices.
  • Collaborate with cross-functional teams, including clinical research, statistical analysis, and regulatory affairs.

Requirements:

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

Technical Expertise:

  • CTMS configuration and administration skills (Having knowledge in CRIO is an advantage).
  • 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.

What We Offer:

A dynamic work environment that fosters professional growth and development. The opportunity to work with a talented team of professionals who are passionate about delivering high-quality results. A competitive compensation package that reflects your value to the organization.

How to Apply:

If you are a motivated and experienced clinical data management professional looking for a new challenge, please submit your application today.

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