Clinical Trials Quality Assurance Specialist

1 week ago

Mangalore, Karnataka, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Clinical Quality Assurance Compliance Specialist

Job Summary:

  • Assume responsibility for overseeing end-to-end clinical trial activities from a quality perspective.
  • Accountable for ensuring Quality Compliance of Clinical Trial Medical Science, Operations, Clinical Trial Supply Management, and Clinical Data Management teams.
  • Review study-related activities, processes, procedures, and adherence to applicable regulations and guidelines to guarantee inspection/audit readiness.

Key Responsibilities Include:

  • Developing and implementing a risk-based approach to Quality Compliance within the function.
  • Identifying team members' job-specific SOP training requirements and ensuring all team members are trained accordingly.
  • Maintaining oversight of training to ensure all team members are up-to-date on each SOP as required.
  • Preparation of SOPs related to QC functions and support in reviewing SOPs specific to Medical Science, Clinical, and Data Management teams.
  • Quality review of clinical trial medical science-related activities, including synopsis, protocol, CSR, and appendices, and SOPs in line with ICH GCP and Indian/global regulatory requirements.
  • Quality review of clinical trial operation-related activities, including site feasibility, site selection visits, site initiation, ethical committee documentation, monitoring-site-specific reports, site documents, logs, and close-out activities in line with ICH GCP and Indian/global regulatory requirements.

Requirements:

  • 5 years' experience in a CRO/Pharma/Biotech organization in Quality with experience of Quality activities in Clinical Research.
  • Strong attention to 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.
  • Experience of working in matrix business environments.
  • Strong track record of success demonstrated through annual performance ratings and/or professional accomplishments and awards.

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