Primary Purpose of Job (Job Summary)
1. Clinical Trial Document Archiving
- Be familiar with the content of clinical trial master file and investigator site file based on the requirements of ICH GCP, China regulation and Roche SOPs, guidance.
- Review the closed clinical trial documents, support archiving responsible to arrange and archive them according to related SOP requirements.
2. Business Support to Department
- Understand ICH GCP, China GCP and related regulation on clinical trials.
- Support SSUS to prepare the essential EC submission package according to required timeline.
- Support SSUS on site budget and contract preparation.
- Maintains and analyzes study data (metrics) on assigned studies. Support SSUS and SSUM to identify opportunities for continuous improvement
- Update and maintain the data in CDE platform according to regulatory and SOP requirements.
3. General Office Duties
- Provide general office support to PDG CCO department staff (including but not limited to photocopying, distributing mail/faxes, scanning, faxing,).
- Organize courier services for documents/ goods pick-up.
- Perform other tasks, as assigned by line manager
Qualification and Experience
- Bachelor degree preferred (4th year student)
- Major in Pharmacy or medical related
- Good ownership and focus on details
- Logical and efficient with highly compliance
- Be willing to learn, think and practice
3. Job Required Competencies
- Good Computer skill for Window 7, Microsoft 2010 (PPT, Excel, Word)
- Strong communication skills
- Fluent English written and oral capability
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