Clinical Trial Operations Specialist

4 days ago


Surat, Gujarat, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 24,00,000
Job Overview

This role involves overseeing clinical trial activities from a quality perspective, ensuring compliance with applicable regulations and guidelines.

">Key Responsibilities
  • Develop and implement a risk-based approach to Quality Compliance (QC) within the function.
  • Identify and decide team member's job-specific SOP training requirements.
  • Prepare SOPs related to QC function and support in review of SOPs specific to Medical science, Clinical team, and Data Management team.
  • Quality review of clinical trial medical science-related activities and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement.
  • Quality review of clinical trial operation-related activities, related tools, plans, and documentation.

Essential Skills:

  • Effective communication and interpersonal skills.
  • Strong analytical and problem-solving abilities.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
  • Excellent organizational and time management skills.
  • Knowledge of quality control principles and practices.

Desirable Skills:

  • Experience in clinical research or quality assurance.
  • Knowledge of regulatory requirements and industry standards.
  • Certification in quality assurance or a related field.

What We Offer:

  • A competitive salary package.
  • Opportunities for professional growth and development.
  • A dynamic and supportive work environment.


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