求職服務專線
台北 02-2912-6104 轉 2
   02-7703-3104 轉 2
意見回饋
廠商求才專線
台北 02-2912-6104
   02-7703-3104
台中 04-3700-6104
上海 86-21-50277104 轉 1
意見回饋

Regulatory & Start-Up Specialist

  • 全職

·Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU
Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and CST. Ensure adherence to
standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project
timelines.
• Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Review, prepare and negotiate site contracts and budgets with sites.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific
information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and
implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory,
ethics ICF and IP Release documents, in line with project timelines.
• Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.
• May perform Site Selection Visits if a trained monitor.
• May participate in feasibility and/or site identification activities.

工作條件

  • 工作經歷: 一年以上
  • 學歷要求: 大學 碩士
  • 語文條件: 英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
  • 其它條件: · Bachelor’s Degree in a related field and 1 year clinical research experience; or equivalent combination of education,
    training and experience
    · In-depth knowledge of clinical systems, procedures, and corporate standards
    · Strong knowledge of medical terminology and regulations
    · Broad knowledge of clinical research
    · Strong knowledge of Microsoft Office and e-mail applications
    · Effective communication, organizational, and interpersonal skills
    · Ability to work independently and to effectively prioritize tasks
    · Ability to manage multiple projects
    · Attention to detail
    · Ability to establish and maintain effective working relationships with coworkers, managers and clients
  •  
  • 歡迎應屆畢業生

福利制度

- 享勞保/健保/含配偶及子女之完善團保制度
- 勞工退休金提撥
- 優於勞基法的15天年假
- 三節禮券
- 完善的教育訓練計劃及生涯發展規劃
- 員工健康檢查
- 員工旅遊、社團活動及團隊 team-building
- 英文學習補助

~以上福利為正職員工享有~

更新日期:2022-01-29

應徵方式

  • 職務聯絡人: 吳小姐
  • 聯絡E-Mail: (請利用104履歷表應徵此工作) 我要應徵
  • 洽: 不接受電洽
  • 洽: 不接受親洽
  • 它: 請至IQVIA全球網站 https://jobs.iqvia.com/en-US/job/reg-start-up-spec-1-r1058892/J3M48567PZK9NYL468C填寫線上履歷,完整填寫者, 優先安排面談.

應徵分析

兩週內6-10人應徵
經歷分佈
新鮮人0%
1~3年0%
3~5年57%
5~10年29%
10年以上14%
學歷分佈
碩士及以上86%
大學14%
專科0%
高中0%
高中以下0%
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