Map iso 9001 certification
Quality System Management
- Ensure that quality management procedures exist, implement them and see they are maintained;
- Report quality status to the Directors and alert them about necessary improvements;
- Make collaborators aware of quality obligations.
- Advise and help Heads of Operations (Director of Clinical Studies, Director of Epidemiological Studies, Data Management Director, Business Development Manager) in setting up quality procedures;
- Implement corrective actions and improvements;
- Test current diagnostic practices and audit procedures;
- Promote discussion on quality practices.
Heads of Operations
(Director of Clinical Studies, Director of Epidemiological Studies, Data Management Director, Business Development Manager)
- Have direct access to both the Scientific Director and Quality Controller;
- Supervise operations, ensure that study results are concordant with study aims, and check that resources are used efficiently.
- Responsible for studies and attainment of contractual objectives;
- Implement procedures in the protocol and demanded by Sponsor;
- Relay quality awareness;
- Provide feedback on the project during its execution.
Other parties involved
(Clinical Research Assistants, Epidemiological Research Assistants, Clinical Study Managers, Epidemiological Study Managers)
- Signal malfunctions and suggest remedies;
- Implement quality procedures;
- Contribute to achieving contractual objectives;
- Listen to what investigators and sponsors say and pass on the information.
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