Clinical Trials Quality Assurance Specialist

2 days ago

Vijayawada, Andhra Pradesh, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Clinical Quality Assurance Compliance Expert

About the Role: We are seeking an experienced Clinical Quality Assurance Compliance Expert to join our team. As a key member of our quality assurance function, you will be responsible for ensuring that our clinical trials are conducted in accordance with relevant regulations and guidelines.

Key Responsibilities:

  • Oversight of Clinical Trial Activities: You will oversee end-to-end clinical trial activities from a quality perspective, ensuring that all study-related processes and procedures meet regulatory requirements.
  • Quality Compliance: You will be responsible for quality compliance activities of our clinical teams, including medical science, operations, and data management.
  • Training and Development: You will establish procedures and trainings to ensure that our teams are equipped to handle quality-related tasks and responsibilities.
  • SOP Development: You will develop and implement Standard Operating Procedures (SOPs) related to quality compliance within our function.
  • Quality Review: You will conduct quality reviews of clinical trial activities, including synopsis, protocol, CSR, and appendices, to ensure adherence to ICH GCP requirements and Indian and global regulatory requirements.

Requirements:

  • Regulatory Knowledge: You have thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations, and other applicable regulations pertaining to clinical trials.
  • Analytical Skills: You have strong analytical skills, with the ability to spot inconsistencies and identify areas for improvement.
  • Communication Skills: You have excellent communication skills, with the ability to articulate complex ideas and concepts to both technical and non-technical audiences.
  • Audit Experience: You have experience handling audits & inspections of DCGI, US FDA, and other regulatory bodies.

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