Clinical Data Lead

10 hours ago


Thoothukudi, Tamil Nadu, India beBeeClinical Full time ₹ 20,00,000 - ₹ 25,00,000
Senior Clinical Data Manager Job Title

We are seeking an experienced Senior Clinical Data Manager to fill a key role in our organization.

  • 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 and clinical data operations.
  • They will also have experience in pharmaceutical, biotechnology, or CRO environment across multiple therapeutic areas.

Key Responsibilities:

  • Lead a team of data managers in the planning, execution, and delivery of clinical trials.
  • Develop and maintain CTMS platforms, ensuring seamless integration with EDC systems.
  • Ensure compliance with regulatory requirements, including HIPAA, FDA, EMA, and ICH-GCP.
  • Collaborate with cross-functional teams to drive business objectives and improve processes.

Required Skills and Qualifications:

  • 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.

Benefits:

  • Opportunity to work on complex clinical trials and develop expertise in data management.
  • Chance to collaborate with experienced professionals and contribute to business growth.
  • Professional development opportunities to enhance skills and knowledge.

Others:

  • Familiarity with electronic systems validation and 21 CFR Part 11 compliance.
  • Understanding of regulatory requirements and industry standards.
  • Able to work effectively in a team environment and communicate clearly.

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