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2 days ago
We are seeking a skilled Clinical Quality Assurance professional to join our organization.
The ideal candidate will possess 5+ years of experience in a Quality department, with expertise in clinical research and quality compliance. They will be responsible for ensuring the protection of human subjects, data reliability, and internal consistency.
Key Responsibilities:
- Develop a risk-based approach to Quality Compliance (QC) within the function.
- Identify and decide on team member job-specific SOP training requirements.
- Prepare SOPs related to QC functions and support 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.
Requirements:
- Strong attention to detail and ability to spot inconsistencies.
- Effective conflict management skills.
- 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 is preferred.
This role offers a unique opportunity to make a meaningful impact in the field of clinical quality assurance.
As a valued member of our team, you will contribute to the development and implementation of quality compliance strategies that ensure the highest standards of quality and patient safety.
We strive to maintain a work environment that promotes collaboration, innovation, and continuous learning.
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