档案管理经理/高级经理
Manager/Senior Manager, Records Management
经理，文件管理
将通过确保上传至TMF的文件符合标准操作规程、ICH GCP指南和其他监管要求，为TMF活动提供支持。该经理将作为TMF主题专家（SME），与研究团队合作，确保临床研究的TMF和CTMS始终处于检查准备状态。
主要职责和任务
· 审核研究团队提供的研究文件，确保其完整性和准确性，并上传至试验主文件（TMF）
· 按照SOP、工作说明和指导文件对提交至TMF的文件进行质量控制
· 确保未通过TMF质量控制和/或TMF质量审查的文件得到有效整改，并在需要时提供最佳实践建议
· 进行TMF质量审查，确保研究文件的完整性、准确性和及时性，确保TMF始终处于检查准备状态
· 为研究团队提供反馈、支持和培训，以提高其对临床试验良好质量文件管理实践的知识和意识
· 根据需要开展TMF教育研讨会/培训
· 解决有关文件归档方式以及TMF系统用户问题的相关问题
· 确保基本文件清单（EDLs）持续维护
· 按适用的SOP对站点基本文件包进行二次审查，以确保站点满足站点激活和试验产品（IP）发布的条件
· 负责临床试验管理系统（CTMS）的维护，包括研究、国家和站点级别的更新，并审核CTMS条目以确保准确性
· 根据需要参与TMF QC工具的开发，以匹配不断变化的业务流程（包括QC工具、QC手册、文档负责人手册、TMF通讯）
· 保持对TMF参考模型、行业最佳实践和与工作职责相关的监管考虑的最新了解
· 协助进行检查/审计相关活动（例如，准备、纠正措施计划）
· 执行其他指派的任务
资格要求
· 需要至少2年的相关临床研究和TMF经验
· 需要了解临床试验流程，有处理临床试验相关文件的经验
· 有电子TMF经验者优先，Veeva优先
· 需要掌握ICH-GCP指南及与临床文件管理相关的监管要求
查看英文原文
The Manager, Records Management
will provide support for TMF activities
by ensuring documents uploaded to the TMF adhere to Standard Operating Procedures, ICH GCP
guidelines
and other regulatory requirements.
The Manager will act as a TMF Subject Matter Expert (SME) and work with the study teams to ensure the TMFs and CTMS for clinical studies are inspection ready at all times.
Essential Duties and Responsibilities
· Review study documents received from the study teams for completeness and accuracy and upload to the Trial Master File (TMF)
· Perform quality control of documents submitted to the TMF per SOPs, Work Instructions and Guidance Documents.
· Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as needed.
· Perform TMF quality reviews to ensure completeness, accuracy and timeliness of study documents to ensure TMFs are inspection ready at all times.
· Provide feedback, support and training to study teams to build knowledge and awareness of good, quality documentation management practices for clinical trials.
· Conduct TMF educational workshops/training, as needed.
· Address TMF questions pertaining to how documents are filed, and user questions related to the TMF system.
· Ensure Essential Document Lists (EDLs) are maintained on an ongoing basis.
· Perform the secondary review of site Essential Document Packages per applicable SOPs to ensure sites meet the requirements for site activation and Investigational Product (IP) release.
· Responsible for Clinical Trial Management System (CTMS) maintenance, including study, country and site level updates and reviewing CTMS entries for accuracy.
· Contribute to TMF QC Tools as needed to match with evolving business processes (incl. QC Tool, QC Manual, Doc Owner Manual, TMF Newsletters).
· Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory considerations as applicable to the job duties.
· Assist with inspection/audit related activities (e.g., preparation, corrective action plans).
· Execute other duties as assigned.
Qualifications
· Minimum 2 years of relevant clinical research and TMF experience required
· Understanding of the clinical trial process, experience in handling clinical trial related documents required
· Previous experience in electronic TMFs, Veeva preferred
· Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management
· Must be self-motivated, well-organized, detail-oriented, and have excellent written and verbal communication skills
· Demonstrated ability to achieve high performance goals and meet deadlines in a fast- paced environment
· Strong organization skills with outstanding attention to detail and follow-through
· Must be highly resourceful and adaptable to effectively support multiple competing demands and changing priorities
- Demonstrated proactive approaches to problem-solving with strong decision-making capabilities
- Must be fully proficient in MS Office Suite and internet research
Salary: $110,000 - $160,000Originally posted on Himalayas