
Clinical Compliance Specialist
4 days ago
Quality Assurance and Compliance Specialist Role Overview:
This role involves overseeing end-to-end clinical trial activities from a quality perspective, ensuring 24x7 Inspection/audit readiness.
- Responsible for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team.
- 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.
- Prepare SOPs related to QC function and support in review of SOPs specific to Medical science, Clinical team and Data Management team.
- Perform quality reviews of clinical trial medical science related activities, like Synopsis, Protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement.
- Conduct quality reviews of clinical trial operation related activities, including 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 requirement, Indian and global regulatory requirement.
Key Requirements and Preferred Skills:
- 5 years' experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department.
- Strong analytical skills and ability to identify inconsistencies is a must, along with 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 as demonstrated through annual performance ratings and/or professional accomplishments and awards.
About the Opportunity: Maxis-Clinical Sciences aims to provide high-quality services to its clients by adhering to the latest regulatory requirements and industry standards.
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