高级临床项目经理（m/w/d） - 远程
Senior Clinical Project Manager (m/w/d) - Remote
职位描述
在Global Clinical Affairs（GCA）组织内工作，高级临床项目经理负责多个研究的临床试验管理，可能是所分配临床研究组或平台的领域专家，包括计划、实施、监督、项目管理和完成由GCA或合同研究组织（CRO）进行的临床试验。高级临床项目经理还将作为其他临床项目经理和CRA的导师。该职位负责多个高复杂度研究的项目负责人，从方案开发到研究执行和结束，均符合良好临床实践以及所有全球、国家和地方法规。向临床项目经理和海外临床事务总监汇报并协作，审查业务请求，评估或制定早期计划和概念以实现最佳研究执行。
具体职责：
- 在有限监督下，负责复杂临床试验的高级临床项目经理
- 确保在整体研究时间表和交付物内执行，并根据其研究进行交付
- 主动识别、升级和管理风险和问题，以确保项目成本效益和及时交付
- 积极与其他GCA职能合作，例如全球项目管理，如适用，DM和统计学
- 与BD业务单元的医学事务部门合作
- 监督/领导并培训特定研究的本地临床资源，例如承包商CRA、CRO等
- 在临床研究执行过程中出现问题时提供批判性思维并相应升级
- 监督研究质量并实施高标准以满足合规要求
- 参与持续改进活动/倡议
- 管理与机构/PI及其他研究相关供应商的关系，例如CRO、中心实验室等
- 制定和/或监督临床研究预算的制定，包括发票审核/批准和每月累计
- 定义、跟踪并报告项目管理时间表属性，如持续时间、相互依赖性、关键里程碑、关键路径和其他关键交付物，包括计划和员工的效率和效果
我们寻找的人选
- 需要学士学位，最好是生命科学、临床或其他相关技术领域
- 至少4年经验
查看英文原文
About the Role
Working within the Global Clinical Affairs (GCA) organization, the Senior Clinical Project Manager is responsible for clinical trial management of multiple studies and may be subject matter expert for group or platform of assigned clinical studies including the planning, implementation, oversight, project management and completion of clinical trials conducted by GCA or Contract Research Organizations (CRO). The Senior Clinical Project will also serve as mentor to other Clinical Project Managers and CRA’s. This role serves as the project lead for multiple studies of high complexity from protocol development through study conduct and close out in compliance with Good Clinical Practices, and all Global, National and Local Regulations. Reports to and collaborates with the Clinical Program Manager and Director, OUS Clinical Affairs to review business requests and evaluate or develop early plans and concepts for optimal study execution.
Furthermore responsibilities in Detail:
- With limited supervision, serve as Senior Clinical Project Manager in complex clinical trials
- Ensures execution within overall study timelines and deliverables and delivers accordingly for his/her studies.
- Proactively identifies, escalates and manages risks and issues to ensure cost-effective timely delivery of the project
- Collaborates actively with other GCA functions, e.g. global project management, as applicable, DM and Statistics
- Collaborates with the Medical Affairs departments of the BD Business Units
- Oversees/leads and trains study-specific local clinical resources, e.g. contractor CRA, CRO, etc.
- Provides critical thinking and escalates accordingly when issues arise during execution of clinical studies.
- Oversees study quality and implements high quality standards in order to meet compliance requirements
- Contributes to continuous improvement activities/initiatives,
- Manages relationships with sites/PIs and other study-related vendors, e.g. CROs, central labs, etc.
- Develop and/or oversee the development of clinical study budgets, including invoice review/approval and monthly accruals
- Defines, tracks and reports on project management schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables including efficiency and effectiveness of plans and staff
About You
- Bachelor's degree required, preferably in the life sciences, clinical or other relevant technical areas
- Minimum of 4 years project management experience
- Minimum 6 years of clinical study experience, (e.g., preferably in medical device, or in IVD, pharmaceutical, biotechnology, CRO) including the proven ability to oversee clinical teams in the conduct and report of multicenter, global complex studies
- Familiarity with CLSI guidelines and other standards
- Demonstrable Project Management skills; PMP Certification is a preferred goal for all Clinical Project Managers;
- Proficient understanding of Good Clinical Practice (GCP), FDA and ISO regulations, MDR/IVDR and current industry practices related to the conduct of clinical studies
- Knowledge of clinical trial concepts and practices, including international clinical research guidelines and regulations
- Strong client and vendor relationship management skills
- Ability to work effectively, mostly independently in international teams, manage multiple projects and work in a fast paced and changing environment
- Demonstrated and effective interpersonal, communications and negotiation skills for a wide variety of audiences
- Ability to work effectively in a virtual environment
- Ability to travel approximately 20%, worldwide
Our Offer
A professional challenge in a highly motivated team, a global environment and with long-term perspectives. A familiar working atmosphere in an innovative environment where your opinion matters. Diversity characterizes our corporate culture and we are convinced that it makes us a stronger team. We value each person as an individual with their abilities and needs. In this sense, we welcome applicants who wish to work part-time, people with severe disabilities and applicants of any gender.
BD ist eines der größten internationalen Medizintechnologie-Unternehmen, das sich den Fortschritt für die Welt der Gesundheit durch Verbesserungen in den Bereichen der medizinischen Forschung, der Diagnostik sowie bei der Behandlung und Pflege von Patienten zum Ziel gesetzt hat. Das Unternehmen entwickelt innovative Technologien, Dienstleistungen und Konzepte, die helfen, die Versorgung der Patienten sowie die Abläufe im klinischen Alltag zu verbessern. Weltweit beschäftigt BD 70.000 Mitarbeiter und Mitarbeiter und ist in fast allen Ländern vertreten, um den drängendsten Herausforderungen bei der Gesundheitsversorgung zu begegnen. BD unterstützt seine Kunden dabei, bessere klinische Ergebnisse zu erzielen, Kosten zu senken, die Effizienz in Klinik und Labor zu erhöhen, die Patienten- und Anwendersicherheit zu verbessern sowie den Zugang zur Gesundheitsversorgung zu verbessern. bd.com
Originally posted on Himalayas