Clinical Governance Specialist

23 hours ago

Pune, Maharashtra, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 19,00,000

Job Title: Clinical Governance Specialist

Overview:

This is an exciting opportunity to play a key role in ensuring the highest standards of quality in clinical trial activities. As a Clinical Governance Specialist, you will be responsible for overseeing end-to-end clinical trial operations from a quality perspective.

Key Responsibilities:

• Develop and implement risk-based quality compliance strategies within the function to safeguard trial participants and data in compliance with applicable regulations and best practices.

• Identify and decide on team members' job-specific SOP training requirements and maintain oversight of training to ensure all team members are trained on each SOP as required.

• Prepare and review SOPs related to quality functions, including medical science, clinical teams, and data management teams.

• Conduct quality reviews of clinical trial medical science activities, such as synopsis, protocol, clinical study reports, and appendices, as well as SOPs, in line with ICH GCP requirements, Indian and global regulatory requirements.

• Review clinical trial operation-related activities, tools, plans, and documentation, such as site feasibility, site selection visits, site initiation, ethics committee documentation, monitoring site-specific reports, site documents, logs, and close-out activities, in line with ICH GCP requirements, Indian and global regulatory requirements.

Requirements:

  • 5 years' experience in a CRO/Pharma/Biotech organization in a Quality department, with experience in quality activities in clinical research departments.
  • Strong attention to detail and ability to spot inconsistencies, along with good conflict management skills.
  • Experience 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 working in matrix business environments preferred.
  • Strong track record of success demonstrated through annual performance ratings and/or professional accomplishments and awards.

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