Clinical Compliance Specialist

1 day ago

Ahmedabad, Gujarat, India beBeeCompliance Full time ₹ 20,00,000 - ₹ 25,00,000
Clinical Quality Assurance Specialist

The Role:

This position will oversee end-to-end clinical trial activities from a quality perspective.

  • Oversight of Clinical Trial Medical Science, Operations, and Clinical Data Management teams' quality compliance.
  • Review of study-related activities, processes, procedures, and adherence to applicable regulations and guidelines.
  • Establishing quality procedures and training that ensure protection of human subjects from research risk, reliability/Integrity of data, and internal consistency.

Main Responsibilities:

  • Identifying and deciding on team member job-specific SOP training requirements.
  • Maintaining oversight of training to ensure all team members are trained on each SOP as required.
  • Preparation and review of SOPs related to QC function and other teams.
  • Quality review of clinical trial medical science and operation-related activities in line with ICH GCP and regulatory requirements.

Required Skills:

  • 5 years of experience in a CRO/Pharma/Biotech organization in the Quality department with experience of Quality activities in Clinical Research.
  • A strong eye for detail and ability to spot inconsistencies.
  • Good conflict management skills.
  • Experience in handling audits & inspections.
  • Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations.

About Us:

We offer a dynamic work environment where you can apply your skills and expertise to contribute to the success of our organization.

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