高级总监 / 全球临床流程管理负责人
Associate Director / Director Global Clinical Process Management Lead
职位名称：高级经理 / 总经理 全球临床流程管理负责人
工作地点：远程（美国）
工作地点类型：远程
工作合同类型：全职
职位级别：
BeOne 正以快速的速度持续增长，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，我们寻找具有高度积极性、协作精神，并且最重要的是，对抗击癌症充满热情的科学和商业专业人士。
职位描述：
全球临床流程管理负责人负责领导和支持全球临床流程管理活动，该角色在全局范围内与 GCO 利益相关者合作，推动 GCO 内高效、一致、可持续且符合监管要求的流程和标准，同时支持能够加强流程的创新想法，并确保从概念到实施的有效对齐和跟进。该角色还确保与 ICH-GCP 和适用的监管要求保持一致。
职责：
- 在 GCO 内执行全球临床流程管理活动，以促进 GCO 流程和标准在适用监管要求方面的效率、一致性、可持续性和合规性。
- 作为 GCOE 的主要联系人，负责一个或多个 GCO 流程，包括 SOP、操作指南和相关标准。
- 参与内容开发，并与 GCO 全球流程负责人和主题专家合作，或根据需要担任全球流程负责人，进行 GCO 程序文件的技术写作，包括 SOP、操作指南、模板和工具。
- 与 GCPC 合作，领导 GCO 流程管理计划，包括评估修订或创建受控文件的需求，并支持持续改进、变更管理和实施活动。
- 识别、支持并推动能够改进 GCO 流程的创新想法，使有效评估、利益相关者对齐以及从概念到实施的跟进成为可能。
- 领导文件审查和批准流程。
- 就其他职能所拥有的影响 GCO 流程和相关标准的流程提供建议并进行审查。
- 与相关的 GCO 和跨职能团队建立并维护有效的合作关系，包括 GCP 合规、学习与发展和其他必要利益相关者。
- 为开发和实施 GCO 流程管理策略和方法做出贡献。
查看英文原文
Job Title: Associate Director / Director Global Clinical Process Management Lead
Job Location: Remote (US)
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
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:
The Global Clinical Process Management Lead is responsible for leading and supporting global clinical process management activities within Global Clinical Operations. Working collaboratively with GCO stakeholders globally, this role promotes efficient, consistent, sustainable, and compliant processes and standards across GCO, while supporting innovative ideas that strengthen processes and ensuring effective alignment and follow-through from concept through implementation. The role also ensures alignment with ICH-GCP and applicable regulatory requirements.
Responsibilities:
- Execute global clinical process management activities within GCO to promote efficiency, consistency, sustainability, and compliance with applicable regulatory requirements across GCO processes and standards.
- Serve as the primary GCOE point of contact for one or more GCO processes, including SOPs, Work Instructions, and related standards.
- Contribute to content development and collaborate with GCO Global Process Owners and Subject Matter Experts, or act as the Global Process Owner as appropriate, in the technical writing of GCO procedural documents, including SOPs, Work Instructions, templates, and tools.
- Lead GCO process management initiatives in collaboration with GCPC, including assessing the need to revise or create controlled documents and supporting continuous improvement, change management, and implementation activities.
- Identify, support, and help advance innovative ideas that improve GCO processes, enabling effective evaluation, stakeholder alignment, and follow-through from concept through implementation.
- Lead document review and approval workflows.
- Advise on and review processes owned by other functions that impact GCO processes and related standards.
- Establish and maintain effective partnerships with relevant GCO and cross-functional groups, including GCP Compliance, Learning and Development, and other stakeholders as needed.
- Contribute to the development and strategic direction of training materials related to GCO processes.
Supervisory Responsibilities:
· Matrix supervisory
Computer Skills:
· Efficient in Microsoft suite (Excel, Outlook, Word, PowerPoint, Project)
Other Qualifications:
· Fluent English (Oral; Written)
- Relevant Bachelor’s degree minimum – preferred science/healthcare discipline
- Minimum of 8 years of experience in pharmaceutical and/or biotechnology sector
- Extensive knowledge of clinical operations process, ICH-GCP and compliance management; including application of clinical trial regulation/s
- Experience in clinical trial process design, harmonization/optimization and implementation.
- Experience working in matrix environment and in global teams
- Excellent interpersonal, problem-solving, negotiation and conflict resolution skills
- Excellent organizational skills and a pre-disposition to quality management and process improvement
- Effective communicator (oral and written)
- Strong presentation skills
Education Required:
· Bachelor’s degree required, master’s degree or other relevant post graduate qualification preferred.
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
Salary Range: $143,300.00 - $193,300.00 annuallyBeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact .
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Originally posted on Himalayas