高级研究启动专员
Senior Study Start-Up Specialist
BeOne持续以快速的速度增长，为有经验的专业人士提供具有挑战性和令人兴奋的机会。在考虑候选人时，我们寻找高度积极、善于合作，并且最重要的是，与我们一样对抗击癌症充满热情的科学和商业专业人士。
职位概述：
· 负责在既定时间表内高质量地完成研究启动、初始及持续提交，并符合ICH/GCP、BeOne的SOP以及当地法规要求。
岗位核心职责：
- 熟悉ICH/GCP、相关国家法规/指南及SOP
- 参与站点选择可行性阶段的讨论
- 站点启动
- 具备从站点选择到激活的各项工作推动和完成能力，包括为站点激活提供时间线输入。
- 利用并扩展现有的站点合作关系数据，高效执行启动工作，尽可能缩短周期。
- ICF/提交
- 具备文档管理/谈判能力，并利用站点关系实现从启动到结题的提交目标。
- 具备文档准备和提交至中央IRB的能力，确保及时审查。
- 确保收集和审核关键文件
- 在CTMS中完成SSU数据录入
- 完成及时且高质量的eTMF归档
- 支持本地流程开发，以优化产出和交付物。
- 为北美地区SSU基础设施的持续改进做出贡献
- 完成分配或需要的其他任务，以实现项目、职能、部门或公司目标。
监督职责：
· 不适用
教育/经验要求：
- 科学或医疗健康领域的学士学位或更高学历优先
- 至少3年临床研究和临床运营方面的渐进式经验，最好是在生物技术、制药行业、CRO或临床站点环境中。
薪资范围（加拿大）：
· 76,000.00 加元 - 95,000.00 加元
全球能力
通过以下十二项全球能力，我们展现“以患者为先”、“追求卓越”、“大胆创新”和“协作精神”的价值观，帮助让更多患者获得更负担得起的药物。
- 促进团队合作
- 提供并征求诚实且可操作的反馈
- 自我意识
- 表现出包容性
- 展现主动性
- 具有企业家思维
- 控制
查看英文原文
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
· Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne’s SOPs, and local regulations.
Essential Functions of the job:
- Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
- Contribute to discussions during the feasibility state of site selection
- Site Start-Up
- Skilled in driving kick-off and completion of tasks from selection through activation, including providing timeline input for site activations.
- Leverage and build upon existing site partnership data to execute start-up efficiently, reducing cycle times wherever possible.
- ICF/Submissions
- Skilled in document management/negotiation and leveraging site relationships to achieve submission targets from start-up through close-out.
- Skilled in document preparation and submission to central IRB to ensure timely reviews.
- Ensure collection and review of essential documents
- Complete SSU data entry in CTMS
- Complete timely and quality eTMF filing
- Support in the development of local workflows to streamline output and deliverables.
- Contribute to the ongoing improvement of SSU infrastructure in North America
- Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals.
Supervisory Responsibilities:
· Not applicable
Education/Experience Required:
- Bachelor’s degree or higher in a scientific or healthcare discipline preferred
- Minimum of 3 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment.
Salary Range Canada:
· 76,000.00 CAD - 95,000.00 CAD
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
Originally posted on Himalayas