Senior Clinical Quality Manager
- Provides competent advice on local regulations related to clinical trials, keeps abreast of changes in local regulations related to clinical trials and keeps local teams and local processes updated.
- Assist with supporting and guiding operational staff in preparing for audits and inspections including analyse risks and develop inspection readiness strategy
- Prepares and presents training as appropriate
- Participate in internal meetings as required and liaise with other departments as necessary
- Maintain required knowledge of applicable regulations and company standards and procedures
- Bachelor degree in a related discipline
- At least 5 years of experience in the pharmaceutical industry, preferably in Clinical Operations/Quality Assurance
- Good knowledge and understanding of ICH-GCP, study management, site management, monitoring
- Excellent communication skills
- Good planning, organisation and problem-solving abilities
- Advance user of MS Office applications
- Demonstrated ability to multitask, prioritize, and complete objectives
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