Senior Clinical Quality Assurance Compliance Specialist

1 day ago

Varanasi, Uttar Pradesh, India beBeeClinical Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

**Job Title:** Clinical Quality Assurance Compliance

We are seeking a seasoned professional to join our team as a Clinical Quality Assurance Compliance Specialist. In this role, you will be responsible for overseeing the quality compliance of clinical trial activities from end-to-end.

**Key Responsibilities:

  • Develop and implement a risk-based approach to quality compliance within the function, ensuring that trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practices.
  • 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 the clinical trial medical science related activities like Synopsis, Protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement.

**Requirements:

To be successful in this role, you must have:

  • 5 years' experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department.
  • Strong eye for detail and ability to spot inconsistencies a must and good conflict management skills.
  • Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations and other applicable regulations pertaining to clinical trials.

**Preferred Qualifications:

  • Experience of working in matrix business environments.
  • Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards.

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