Senior Clinical Quality Assurance Specialist

22 hours ago

Madurai, Tamil Nadu, India beBeeCompliance Full time ₹ 1,00,00,000 - ₹ 2,00,00,000
Clinical Quality Assurance Compliance Role

Our organization seeks a highly experienced Senior Manager to oversee end-to-end clinical trial activities from a quality perspective. The ideal candidate will ensure compliance with regulations and guidelines, establishing procedures and trainings to protect human subjects and ensure data reliability.

The successful applicant will be responsible for developing and implementing a risk-based quality compliance approach within the function, identifying and deciding team member's job-specific SOP training requirements. Additionally, they will prepare SOPs related to QC function and support in review of SOPs specific to Medical science, Clinical team, and Data Management team.

Key Responsibilities:

  • Develop a risk-based quality compliance approach 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.
  • Quality review of clinical trial operation-related activities, related tools, plans, and documentation like site feasibility, site selection visit, site initiation, Ethic committee documentation, monitoring – site-specific reports, Site Documents, logs, and close-out activities 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.
  • 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.

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