
Clinical Assurance Professional
4 days ago
Clinical Quality Assurance Compliance Specialist
As a Clinical Quality Assurance Compliance Specialist, you will be responsible for overseeing end-to-end clinical trial activities from a quality perspective. This includes ensuring that all study related activities, processes, and procedures adhere to applicable regulations and guidelines.
Key Responsibilities:
- Establishing and maintaining procedures and trainings for teams to ensure protection of human subjects, reliability/integrity of data, and internal consistency.
- Developing and implementing a risk-based approach to Quality Compliance within the function.
- Preparing SOPs related to QC functions and supporting review of SOPs specific to Medical Science, Clinical Team, and Data Management Team.
- Quality reviewing clinical trial medical science activities like synopsis, protocol, CSR, and appendices in line with ICH GCP requirements.
- Quality reviewing clinical trial operation activities, tools, plans, and documentation like site feasibility, site initiation, monitoring - site specific reports, and close-out activities in line with ICH GCP requirements.
Requirements:
- 5 years' experience in a CRO/Pharma/Biotech organization in Quality Department with experience in Quality activities in Clinical Research Department.
- Strong eye for detail and ability to spot inconsistencies.
- Good conflict management skills.
- Experience in handling audits & inspections of regulatory bodies.
- Thorough knowledge of recent GCP guidelines and applicable regulations.
- Experience of working in matrix business environments preferred.
- Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments.
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