美国东海岸这边的人选最好，有临床研究项目经验，中英双语

化药（疼痛、神经类产品）

Clinical Project Manager

The Senior Clinical Project Manager is responsible for assisting in the strategic planning, oversight, and execution of all clinical trials for assigned program/s. Responsibilities include creating timelines and budgets, overseeing day-to-day operations, ensuring studies are conducted in accordance with ICH GCP, regulatory requirements and within established timelines and budgets. Additionally, the incumbent will be responsible for leading cross-functional teams and managing relationships with investigator sites, vendors, and consultants.
The Manager is accountable for operational planning and execution at the study level with responsibility for clinical study plan and execution (from planning start-up, conduct, reporting and close out) including timeline, quality, and budget. A key focus will be the selection, oversight of and interactions with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission.
Job responsibilities：
1. Responsible for managing the entire lifecycle of clinical trial projects, overseeing clinical trial inspections, and ensuring that all trials are conducted strictly in accordance with clinical trial protocols, standard operating procedures/internal operating procedures, and relevant ICH GCP/national policy and regulations.
2. Responsible for selecting and managing the contract research organization, conducting comprehensive quality control and management of the research projects, completing the comprehensive initiation, execution, center closure and reporting of clinical trials in China and abroad on time, and communicating and coordinating with other department personnel related to the project in a timely and efficient manner.
3. Collaborate with other functional departments and suppliers to contribute to the implementation of patient recruitment strategies and emergency plans.
4. Responsible for timely communication with superiors in accordance with internal SOP and GCP, selecting experimental centers and researchers, and developing experimental budgets, control management budgets, and budget usage reports.
5. Responsible for assisting in filling out relevant reports and test records, ensuring the accuracy, effectiveness, and completeness of data collected at the test site; Ensure that all adverse events (AE)/serious adverse events (SAEs) are reported and recorded within the specified reporting time frame. For AEs/SAEs, ensure that they are consistent with all collected data and information in source documents.
6. Responsible for providing feedback on issues during the monitoring process, ensuring that researchers complete data entry and answer questions within the expected time frame.
7. Collaborate closely with contract research organizations to ensure that quality issues identified during daily monitoring visits, QA audit visits, and other types of visits are resolved, and to ensure the completion of relevant corrective and preventive measures (CAPA). Willing to travel as business needs arise.
8. Responsible for the allocation of project related documents, materials, and drugs, and timely communication with all parties regarding safety, materials, timelines, and financial budgets.
9. As the external representative of the company and its ******s, timely convey important company information to researchers, cultivate and maintain good relationships with researchers, Good at coordinating relationships and conflicts between various projects.
10. Check the integrity of the research files to ensure that the document retention requirements are met, including being always stored in a safe place; Review and sign all routine visit reports and other TMF documents responsible for the project.
11. Lead/participate in supplier/on-site budget negotiations and assist in developing clinical trial protocols when necessary.
12. Participate in the preparation, review, and finalization of clinical research related documents, such as protocols, protocol revisions, and clinical research reports.
13. Complete other tasks assigned by direct superiors and leaders.
Job Requirements：
1. 8 years clinical research experience in an industry setting and a minimum of 5 years project-lead or management experience, experiences of managing late-stage clinical trial projects in USA is preferred.
2. Previous experience managing clinical operations staff across multiple programs.
3. Bachelor's and/or master's degree in a scientific discipline, MD, RN, BSN, degree or equivalent.
4. Interpersonal Skills - Must have strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner. Demonstrated effective team leadership in cross-functional matrix teams.
5. Communication Skills - Excellent oral and written communications with ability to present data to all levels of audiences.
6. Productivity/Organizing/Planning - Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously. Ability to proactively identify and take appropriate initiatives to fulfil the requirements of the role. Ability to maintain a high level of productivity with minimal supervision.
7. Strategic Thinking - Strong capability of strategic thinking and proposing innovative solutions to issues.
8. Collaboration & Teamwork - Advanced competence in collaboration & teamwork, communications, influence, conflict resolution, strategic agility, planning & organizing, team building, driving results and problem solving.
9. Experience in writing clinical study protocols, informed consent forms, and other clinical documents.
10. Detailed oriented, with strong coherent and logical sense in writing English and/or Chinese documents; strong editorial competences to meet high document standard per regulatory requirements.
11. Solid understanding of NMPA and other regulatory requirements that may impact global clinical studies.
12. Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management.
13. Willing and capable to manage multiple projects, negotiate budgets, timelines, and responsibilities.
14. Fluent in both Chinese and English, proficient in operating office software.
Other information：
1. Reported to: CMO & SVP
2. Location: USA (East Coast preferred，Homebase）


岗位名称：临床项目经理

工作职责:
1、负责临床试验项目全生命周期的管理，负责临床试验的监查工作，确保所有试验严格按照ICH GCP要求、临床试验方案、标准操作程序/内部操作流程和国家行业相关法规进行；
2、负责对合同研究组织筛选和管理，对所负责的研究项目进行全面的质量控制与管理，按时在预算内完成临床试验在国内、国外的全面启动、执行及中心关闭相关工作，并及时高效的与项目相关的其他部门人员进行沟通和协调；
3、与其他职能部门及供应商合作，为患者招募策略和应急计划的实施做出切实可靠的按排计划；
4、根据内部SOP和GCP负责与上级主管及时沟通，选定试验中心、研究者并制定试验预算、控制管理预算、预算使用情况报告；
5、负责协助填写相关报告及试验记录，确保试验现场收集数据的准确性、有效性和完整性；确保所有不良事件(AE) /严重不良事件(SAEs)在规定的报告时限内报告并记录。对于AEs/SAEs，确保它们与收集到的所有数据以及源文档中的信息一致；
6、负责监查过程中的问题反馈，确保研究者在预期的时间内完成数据录入和质疑解答；
7、与合同研究组织紧密合作，确保日常监查访视、QA稽查访视及其他类型的访视中发现的质量问题得到解决，确保相关纠正措施和预防措施(CAPA)的完成；能够进行工作相关的旅行
8、负责项目相关文件、物资及药品调配，与各方及时沟通安全、物资、时间点及财务预算的相关内容；
9、作为公司及客户的对外代表及时向研究者传递公司重要信息，培养并保持与研究者的良好关系；善于协调各项目间的关系与冲突；
10、检查研究文件的完整性，确保文档保存要求得到满足，包括任何时候都要保存在安全的地方；审阅并签署所有负责项目的例行访视报告与其他TMF文件；
11、领导/参与供应商/现场预算谈判，并在必要时协助制定临床试验协议；
12、参与临床研究相关文件的准备、**和定稿，如方案、方案修订、临床研究报告；
13、完成直接上级和领导交办的其他工作。
任职资格与要求:
1、本科及以上学历，临床医学、临床药学、药学、生物技术、护理等相关专业；
2、8年以上相关行业临床运营工作经验，具备项目管理经验，有2-3个临床试验项目管理经验者优先；
3、熟悉掌握GCP及ICH-GCP等药物临床试验相关法律法规；
4、良好的沟通协调能力，能独立与研究中心、临床工作者和CRO公司进行良好的沟通和协调，具备一定的谈判技巧；
5、很强的责任心、自我学习能力、问题分析和解决能力；有效的时间管理能力；能适应出差；
6、撰写临床研究方案、知情同意书和其他临床文件的经验；
7、高质量的中、英文编辑和撰写能力；注重细节和严密的逻辑思维能力
7、有较强的战略思维能力，并能提出创新的问题解决方案；
8、愿意并有能力管理多个项目，协商预算、时间表和责任；
9、中英文双语流利，熟练操作办公软件。
其他信息：
1、汇报对象: 首席医学官兼高级副总裁（CMO & SVP）
2、工作地：美国（Homebase，东海岸为佳）