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职位介绍:
临床研究相关工作:因参与的研究的阶段不同而有所侧重
(1)对研究中心进行可行性调查及评估(确定医院的相应科室是否可以加入研究);
(2)准备并协调伦理资料的递交;
(3)负责研究中心的启动,管理及项目结束工作;
(4)制定研究中心项目入组计划,并确保患者入组按计划完成;
(5)对研究项目数据进行监查工作,包括对患者病历的监查、数据收集、原始病历的一致性、药品管理和样本管理相关监查。以确保临床研究按照相关法规及公司SOPs进行;
(6)对研究人员进行项目相关培训,并确保相关的培训资料完整、准确;
(7)确保临床研究数据准确,合理且完整的收集,临床研究文件及时准确的归档;
(8)确保安全性信息按照相关法规及公司SOPs及时上报;
(9)定期参加项目会,向项目经理汇报并记录研究中心的进展和问题;
(10)与内部和外部临床研究参与者,特别是研究者、研究协调员和研究中心其他工作人员建立并保持良好的工作关系。
各类培训机会:
(1)内部培训:网上和课堂培训,岗位相关和研究相关培训;
(2)外部培训:专业相关外部培训课程,行业会议及治疗领域会议等。
• 本科及以上学历
• 医学、药学或生物学相关专业;
• 成绩优秀和有实习经验者优先;
• 熟悉电脑应用,包括Word,Excel,Outlook,Power Point等办公软件;
• 可以接受一定强度的出差;
• 英文和中文读写流利;
• 具有较强的沟通和合作能力
工作地点:
北京、上海、南京
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职位介绍:
• Supports to create, revise and maintain study design and outlines, scientific rationale, study protocol aligned with China development strategy and the clinical study plan.
• Support to implement study protocol including knowledge transfer to clinical study execution in China.
• Support create and update the study related documents, including medical review plan/summary, Investigator’s Brochure (IB) (Chinese translated version), training materials for study team, etc.
• Play a key role in the medical review of the data for the local/regional studies, including medical review on eligibility, efficacy, safety, coding, protocol deviation, etc. In addition, handle medical inquiries from/to data management, study operation team or investigators.
• Participate in investigator meetings, ensuring investigator engagement and managing sites to ensure study treatment discontinuation decisions are made per protocol and aligned with partners within the study team.
• Work with safety, data management teams and Data Monitoring Committee to make timely decisions regarding study objectives.
• Supports to create Clinical Study Report (CSR) of the local/regional study, or Chinese cohort report of the global study.
• Supports to create regulatory filing documents.
• Communicate and cooperate with internal and external customers.
• Develop and maintain academic relationship and collaboration with KOLs and other critical stakeholders.
Education /Training background:
A graduate degree of clinical, biomedical, pharmacy, nursing, scientific degree with drug development experience is required. A MD or Ph.D. is strongly preferred.
Knowledge/Skills:
• Expertise of therapeutic area and knowledge of relevant products is highly desired.
• Knowledge of clinical development process and HA (especially CFDA) requirements.
Job experience:
Proven clinical drug development or medical affairs experience within a pharmaceutical company.
Competency:
• High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to clinical research and the highest personal and ethical standards
• Ability to acquire and assimilate knowledge in different disciplines, disease, products and therapeutic areas
• Analytical thinking
• Excellent communication and team collaboration skills
• Good presentation skills
Others:
Excellent English abilities of listening, speaking, reading and writing; same level of CET-6
Location:
Beijing