Clinical Quality Assurance Specialist
1 day ago
As a senior member of the Clinical Quality Assurance Compliance team, you will be responsible for overseeing all clinical trial activities from a quality perspective.
You will ensure that all study-related activities, processes, procedures, and adherence to applicable regulations and guidelines are in place to guarantee 24/7 inspection and audit readiness.
Develop and implement a risk-based approach to Quality Compliance within the function, ensuring the integrity of data and protection of human subjects from research risk.
Maintain oversight of training programs to ensure team members are equipped with the necessary skills and knowledge to perform their roles effectively.
Prepare and review SOPs related to QC functions and provide support in the review of SOPs specific to Medical Science, Clinical, and Data Management teams.
Conduct quality reviews of clinical trial medical science-related activities, including Synopsis, Protocol, Clinical Study Report (CSR), and appendices, as well as SOPs in line with ICH GCP requirements.
Ensure compliance with Indian and global regulatory requirements throughout the clinical trial operation process.
Utilize strong analytical skills to identify inconsistencies and manage conflicts effectively.
Prioritize experience in handling audits and inspections, as well as thorough knowledge of recent GCP guidelines, ICMR guidelines, and other relevant regulations.
A successful candidate will possess a proven track record of success, demonstrated through annual performance ratings and professional accomplishments.
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