Clinical Quality Assurance Specialist

12 hours ago

Kollam, Kerala, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 26,00,000

Clinical Quality Assurance Compliance Role Overview

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As a key member of our clinical quality assurance compliance team, you will be responsible for ensuring the integrity and reliability of our clinical trial data.

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  • This role involves overseeing all aspects of end-to-end clinical trial activities from a quality perspective, ensuring compliance with applicable regulations and guidelines.","
  • You will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science teams, Operations teams, Clinical Trial Supply Management (CTSM) teams, and Clinical Data Management teams.","
  • Develop and implement a risk-based and flexible approach to Quality Compliance (QC) within the function, ensuring trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practices.","
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Key Responsibilities:

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  • Establish procedures and trainings to ensure protection of human subjects from research risks, reliability/Integrity of the data, and internal consistency and Quality Compliance measures.","
  • Identify and decide team member's job-specific SOP training requirements, maintaining oversight of training to ensure all team members are trained on each SOP as required.","
  • Preparation of SOPs related to QC functions and support in review of SOPs specific to Medical science, Clinical teams, and Data Management teams.","
  • 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 requirements, Indian and global regulatory requirements.","
  • 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 requirements, Indian and global regulatory requirements.","
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Required & Preferred Skills:

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  • 5 years' experience in a CRO/Pharma/Biotech organization in Quality departments with experience of Quality activities in Clinical Research departments.","
  • 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.","
  • Strong track record of success demonstrated through annual performance ratings and/or professional accomplishments and awards.","
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