研究启动专员 II
Study Startup Specialist II
我们是一家注重员工、客户、合作伙伴以及工作质量的公司。一家成立于1995年的动态全球公司，我们汇聚了3000多名有动力、有奉献精神且充满热情的个人。我们在医学科学的最前线工作，改变人们的生活，将新药带给需要的人。
如果你觉得是时候在一个真正关注员工成长的公司中展现你的技能和知识，那么 PSI 是适合你的选择。
提升你的职业生涯，带领国家层面的项目启动过程。你将支持临床研究团队，确保 PSI 项目顺利且按时启动。
你将：
· 与项目团队合作进行站点启动流程
· 协助站点协议、合同谈判和预算谈判
· 收集站点文件用于 IRB/IEC 提交和/或 IP-RED 流程
· 协调研究专用文件的翻译和审核
· 根据需要识别并升级项目特定问题
· 准备并提交研究资料至站点、监管机构、IRB/IEC
· 准备 IP-RED 包装
· 支持试验药物和临床研究物资的初始分发至站点
· 确保与试验站点、非现场设施和供应商之间的信息和文件交换
· 参与制定站点特定的启动时间表和入组预测，并负责达成站点启动目标
- 生命科学专业本科/大学学历，或同等教育、培训和经验组合
- 至少 2 年完整的项目启动经验
- 英语和法语具备全职专业水平
- 具备良好的沟通和组织能力
- 能够在各个层级进行协商和建立关系
我们提供：
· 优越的工作条件
· 大量的培训和友好的团队
· 有竞争力的薪资和福利包
· 个人和职业发展的机会
· 对于此职位，PSI 不会雇佣目前或未来需要工作签证赞助的个人。
做出正确的选择，让你的职业生涯迈向全新高度。加入这家关注员工并投资于其职业发展和成功的企业。
查看英文原文
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3.000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
Take your career to the next level and lead challenging study activation process on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time.
You will:
· Collaborate with the project team for site activation processes
· Facilitate site agreement, contract negotiations and budget negotiations
· Collect site documents for IRB/IEC submission and/or IP-RED process
· Coordinate translation and review of study-specific documents
· Identify and escalate project-specific issues as needed
· Prepare and submit the study dossiers to sites, competent authorities, IRBs/IECs
· Prepare IP-REDs packages
· Support initial distribution of Investigational Product(s) and clinical study supplies to sites
· Ensure exchange of information and documentation with investigational sites, off site facilities and vendors
· Participate in development of site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets
- College/University degree in Life Sciences or an equivalent combination of education, training and experience
- At least 2 years of full-scope Study Startup experience.
- Full professional working proficiency in English and French.
- Well-developed communication and organizational skills
- Ability to negotiate and build relationships at all levels
We offer:
· Excellent working conditions
· Extensive training and friendly team
· Competitive salary and benefits package
· Opportunities for personal and professional growth
· For this position, PSI is not hiring individuals who require work visa sponsorship for employment now or in the future.
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.