Sr. TMF Specialist - Contract
职位简介：生物联合聘请一位高级 TMF 专家，负责维护 TMF 系统的运营方面和支持 TMF 相关活动。这是一个约6个月的合同职务。基本责任：· 将文件上传到 TMF 中 ·执行 TMF 中的文档 QC · 授予/撤销用户访问 · 发送每周报告以确保及时解决任何悬而未决的质量问题 · 有定期的 TMF 功能 QC 审查周期 · 进行完整性检查并确保预期文件列表 (EDL) 的准确性 ·参与监督评估 CRO 拥有的 TMFs · 根据需要协助 TMF 调整 · 根据需求管理 TMF 活动 · 根据要求监督 TMF 转移 · 根据必要性支持 TMF 档案保存 · 根据需与功能区域内容所有者直接合作 · 根据情况参与审计并协助进行检查准备活动 · 与 CRO,供应商和跨职业团体合作以确保遵守 TMF 期望 教育要求：· 从认可机构或同等实践经验获得学士学位。· 至少5年相关 TMF 经验。首选技能：· 基本了解文件系统和组织工具 · 了解 GCP/ICH 和 CFR 法规 ·熟练使用微软办公产品 - Word,Excel,Powerpoint,Sharepoint ·熟悉 CDISC 试验主文件参考模型结构 ·经历 Veeva Vault 临床 (eTMF) ·能够独立工作并优先任务的能力补偿：预期薪酬率为每小时40至50美元，取决于体验和位置。最初发布在喜马拉雅山。
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Position Summary:
Biomea Fusion is hiring a Sr. TMF Specialist, who will be responsible for maintaining the operational aspects of the TMF system and supporting TMF-related activities. This is a contract position for approximately 6 months.
Essential Responsibilities:
- Uploading documents into the TMF
- Performing QC of the documents in the TMF
- Granting/Revoking User Access
- Sending out weekly reports to ensure timely resolution of any outstanding Quality Issues
- Owning Periodic TMF Functional QC Review cycles
- Leading Completeness Checks and ensuring accuracy of the Expected Document Lists (EDLs)
- Participating in Oversight Reviews of CRO-owned TMFs
- Assisting in TMF Reconciliations as needed
- Management of TMF activities as needed
- Overseeing the transfer of TMFs as needed
- Supporting the archival of TMFs as needed
- Working directly with functional area content owners as needed
- Participating in audits and assisting with inspection readiness activities as needed
- Partnering with CROs, vendors, and cross-functional groups to ensure adherence to TMF expectations
Education Requirement:
- Bachelor’s degree from an accredited institution or equivalent practical experience.
- At least 5 years of relevant TMF experience.
Preferred Skills:
- Fundamental understanding of filing systems and organization tools
- Knowledge and understanding of GCP/ICH and CFR Regulations
- Proficiency with Microsoft Office Products - Word, Excel, Powerpoint, Sharepoint
- Familiarity with the CDISC Trial Master File Reference Model structure
- Experience with Veeva Vault Clinical (eTMF)
- Ability to work independently and prioritize tasks
Compensation:
The expected compensation rate is $40 to $50 per hour, dependent on experience and location.
Originally posted on Himalayas