Clinical Trial Quality Governance Specialist

1 week ago

Kurnool, Andhra Pradesh, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 20,00,000
Clinical Quality Assurance Compliance Officer

We are seeking a seasoned Clinical Quality Assurance Compliance expert to oversee the entire clinical trial lifecycle from a quality perspective. This role will be accountable for ensuring compliance with relevant regulations and guidelines to guarantee inspection/audit readiness.

Main Responsibilities:

  • Develop and implement a risk-based approach to Quality Compliance (QC) within the function to safeguard trial participants and data in compliance with regulatory requirements and best practices.
  • Identify and decide team member's job specific SOP training requirements and maintain oversight of training to ensure all team members are trained on each SOP as required.
  • 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.
  • 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.

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