- Act as a subject matter expert on process/quality/training. Clarifyinquiries received from operational team. Provide expert advice/opinion and counsel on matters of process/quality/training compliance and interpretation.
- Collaborate with teammembers to identify improvement opportunities in process/quality/training based on performance data
- Prepare scope and roadmap of improvement for review board
- Execute, implement, and manage improvement according to the agreedscope and timelines
- Perform impact analysis, develop communication/training plan, and create materials for the roll out of the improvement
- Promote and encourage best practice for assigned area
- Develop system & tool to track process/quality/training compliance
- May oversee activities within the team and provides appropriate supervision to the members
- Propose and lead strategic enhancement of existing process/tool/tracking system with a drastic approach for enhancing the efficiency in Japan CTO
- Enhance process/tool/tracking system in an appropriate manner based on the feedback of CTO or other functions in CDS Japan
- May act as process owner for the procedures developed local
- Develop company-wide, long term preventative strategies to eliminaterepeated findingswith CTO, QA, GQC and relevant global teams
- Collaborate with QA and GQC to analyze issue/CAPA trend in addition to findings from audits and CQC visits etc. on regular basis
- Act as CAPA coordinator and as primary point of contact for all issues
- Review and provide input for CAPA responses ensuring consistency across project teams and track CAPAs in state of compliance
- Maintain quality related process/tools/tracking system
- Monitor quality performance
- May act as SOP liaison and communicate with Global SOP liaison. Communicate updates on SOPs to Japan CTO.
- Proposes strategic training planning with drastic approach
- Asses and identify training needs based on the feedback from CTO, other functions and process owners. Developtrainings based on the identified needs.
- Develop and deliver practical training based on results and trend analysis from findings of CQC, CMP, Site Audit etc. to improve quality of clinical trials
- Tailor and deliver global training programs in a variety of formats (virtual, workshops, etc.)predominantly for Japan CTO to fit the Japanese learning and clinical research environment. Communicate with global training team and relevant local functions (HR, GQC, QA, etc.) to ensure synergy of the over-all training process and goal alignment.
- Perform follow-up after training to enhance existing training course
- Update training materials and contents in a timely manner aligning global/local requirements and reflecting feedback from training participants
- May serve as Train-the-Trainer instructor to ensure consistent
- GCP(Good Clinical Practice) の知識と実務経験
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