临床团队经理 / 高级（CTM）– 血液肿瘤
Clinical Team Manager / Sr. (CTM) – HemOnc
职位名称：临床团队经理 / 高级（CTM）– 血液肿瘤
工作地点：远程，北卡罗来纳州，美国
工作地点类型：远程
工作合同类型：全职
职位级别：
工作时间安排
标准（周一至周五）环境条件
办公室职位描述
作为临床试验经理加入我们——在创新的最前沿产生影响
临床试验经理负责在与客户签订的合同规定的时间内实现最终的临床成果（通常为按研究方案规定的可评估患者的干净数据）。临床试验经理在项目问题的数据基础上做出良好的商业决策，并在经验丰富的团队成员或直线经理的支持下进行。确保所有临床成果满足客户的时效/质量/成本期望。通过高效管理临床团队，确保临床活动在合同范围内进行，从而保持盈利能力。该职位涉及处理低到中等复杂度的项目，并作为CTM团队的一员。
你将负责：
• 管理分配的研究项目的全部临床操作和质量方面的工作，这些研究项目复杂度较低到中等，并符合ICH GCP。根据项目特定要求，可能在小型和/或较不复杂的项目中承担临床研究经理（CSM）职责。
• 与数据质量计划一起开发临床工具（例如，监查计划、监查指南）。参与制定主行动计划（MAP），以提供临床相关文件。确保试验主文件（本地和中央）的相关部分及时建立、组织、内容和质量。可能参与设计和开发CRF、CRF指南、患者知情同意模板和其他协议特定文件。与项目经理合作准备、组织并为客户会议（包括投标答辩和交接会议）进行演示。
• 根据需要与临床团队和其他部门协作，以满足项目的交付成果。定期与团队沟通并主持团队会议，以确保时间表、资源、互动和质量得到维持。负责在研究中实施并培训标准化的临床监查流程，并根据公司标准政策执行。负责及时归档文件和研究材料，供部门使用。
• 确保所有临床相关文档和资料按照公司政策和法规要求进行管理和保存。
查看英文原文
Job Title: Clinical Team Manager / Sr. (CTM) – HemOnc
Job Location: Remote, North Carolina, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as a Clinical Trial Manager - Make an Impact at the Forefront of Innovation
The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs.
What You'll Do:
• Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.
• Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
• Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
• Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
• May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
• May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees.
• May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
Education & Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 5+ years of relevant experience in clinical research, including clinical trial operations, study management, clinical monitoring, or related clinical research activities.
• Transferable experience in healthcare, nursing, medicine, or related disciplines may be considered in combination with clinical trial experience where the candidate demonstrates significant clinical expertise, therapeutic area knowledge, and direct patient care responsibilities.
• Preferred candidates must have:
- Must have FSO/CRO experience.
- Must have Global CTM experience managing global teams.
- Indication experience: Ovarian, Sickle Cell, Non-Hodgkins Lymphoma, Multiple Myeloma, Glioma, Head and Neck, Pancreas, Prostate, Non-Small Cell Lung, Breast, Colorectal, Radiopharmaceutical, Cell and Gene Therapy, and/or CART-T.
Knowledge, Skills, Abilities:
• Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
• Good planning and organizational skills to enable effective prioritization of workload
• Solid interpersonal and problem-solving skills to enable working in a multicultural matrix organization
• Capable of working effectively in a changing environment with complex/ambiguous situations
• Familiarity with the practices, processes, and requirements of clinical monitoring
• Good judgment and decision-making skills
• Effective oral and written communication skills, including English language proficiency
• Capable of evaluating workload against project budget and adjusting resources accordingly
• Sound financial acumen and knowledge of budgeting, forecasting and fiscal management
• Strong attention to detail
• Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
• Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently drives to site locations and frequently travels both domestic and international.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.
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Originally posted on Himalayas