高级CTM - 神经科学
Senior CTM - Neuroscience
工作时间
标准（周一至周五）
工作环境
办公室
职位描述
作为高级临床团队经理加入我们，在创新的最前沿产生影响。
高级临床团队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交付成果（通常为符合研究方案中规定的可评估患者的干净数据）。高级临床团队经理在有经验的团队成员或直线经理的支持下，对项目问题的数据进行解读，并做出良好的商业决策。确保所有临床交付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。该职位涉及低到中等复杂度的项目，并作为临床团队经理（CTM）团队的一部分工作。
我们正在寻找一位有经验的CTM加入我们的神经科学团队。我们希望候选人具备以下适应症方面的丰富经验：
- 眼科：普通眼科、糖尿病性黄斑水肿和地理萎缩
- 罕见疾病：重症肌无力、亨廷顿病、ALS、DMD、CIDP、DM1（肌强直性营养不良）和FSHD - 具备CAR-T经验者优先
- 睡眠、癫痫和/或精神科（抑郁症和精神分裂症）
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，这些研究具有高复杂性，并符合ICH GCP要求。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）的职责。
• 与数据质量计划协作开发临床工具（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（TMF）相关部分的及时建立、组织、内容和质量（本地和中央）。可能参与CRF、CRF指南、患者知情同意模板和其他协议特定文件的设计和开发。与项目经理合作准备、组织并为客户会议（包括投标防御和交接会议）进行展示。
• 根据需要与临床团队及其他部门协作，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。
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Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join us as a Senior Clinical Team Manager - Make an Impact at the Forefront of Innovation.
The Senior Clinical Team 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 Senior Clinical Team 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.
We are looking for an experienced CTM to join our Neuroscience team. We are looking for candidates with extensive experience in the following indications:
- Ophthalmology: General ophthalmology, Diabetic Macular Edema & Geographic Atrophy
- Rare Disease: : Myasthenia Gravis, Huntington's, ALS, DMD, CIDP, DM1 (myotonic dystrophy) and FSHD - CAR-T experience a plus
- Sleep, Epilepsy, and/or Psychiatry (Depression & Schizophrenia)
What You'll Do:
• Manage all clinical operational and quality aspects of allocated studies, of high 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
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
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 acument 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.
Originally posted on Himalayas