临床执行部实习生

Chine, Shanghai, Shanghai

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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

1. Education/Qualifications

  • Bachelor degree preferred (4th  year student)
  • Major in Pharmacy or medical related

2. Personality

  • 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

Roche is an equal opportunity employer.

Vocational & Development Programs, Vocational & Development Programs > Stage/Internat