Clinical Quality Assurance Specialist

17 hours ago


Kolkata, West Bengal, India beBeeCompliance Full time ₹ 25,00,000 - ₹ 35,00,000
Clinical Quality Assurance Specialist

We are seeking an experienced professional to oversee clinical trial activities from a quality perspective.

This role will be accountable for ensuring that all study-related activities, processes, procedures, and adherence to applicable regulations and guidelines are met.

The successful candidate will establish procedures and trainings for teams to protect human subjects from research risk, ensure data reliability/integrity, and internal consistency, while maintaining Quality Compliance measures.

Key Responsibilities:

  • Develop and implement a risk-based approach to Quality Compliance 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 like Synopsis, Protocol, Clinical Study Report (CSR), and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement.

Requirements:

  • 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, good conflict management skills.
  • Must have experience in handling audits & inspections of DCGI, US FDA.
  • Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations, and other applicable regulations pertaining to clinical trials.
  • Experience of working in matrix business environments preferred.
  • Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards.

About this role

We offer a competitive salary and benefits package, opportunities for career growth and development, and a dynamic work environment.



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