
Clinical Quality Compliance Specialist
17 hours ago
Job Summary
">This role is responsible for overseeing end-to-end clinical trial activities from a quality perspective. The ideal candidate will have 5+ years of experience in Quality Assurance and a strong understanding of GCP guidelines, ICMR regulations, and Drugs and Cosmetic Act requirements.
Key Responsibilities- Develop and implement risk-based quality compliance strategies to ensure trial participants and data are safeguarded.
- Prepare SOPs related to QC functions and review SOPs specific to Medical Science, Clinical, and Data Management teams.
- Conduct quality reviews of clinical trial medical science-related activities, such as synopsis, protocol, CSR, and appendices.
- Review clinical trial operation-related activities, including site feasibility, selection visit, initiation, and close-out.
- Identify and decide team member's job-specific SOP training requirements.
- Strong eye for detail and ability to spot inconsistencies.
- Good conflict management skills.
- Experience handling audits and inspections with DCGI and US FDA.
- Thorough knowledge of recent GCP guidelines, ICMR guidelines, and applicable regulations.
- Experience working in matrix business environments preferred.
A dynamic work environment with opportunities for growth and professional development.
How To ApplySend your resume and a cover letter outlining your qualifications and experience.
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