临床研究经理
Clinical Research Manager
TFS HealthScience 是一家领先的全球中型合同研究组织(CRO),与生物技术和制药公司合作,为其整个临床开发旅程提供支持。我们的专长包括全方位服务能力、资源调配和功能服务(FSP)解决方案。
作为临床研究经理(CRM)加入我们的团队,工作地点为阿根廷居家办公。
关于该职位
作为眼科团队的一员,您将与充满热情和创新精神的专业人士共同工作,确保客户实现其目标。
临床研究经理(CRM)负责协调和监督研究期间的国家和机构管理活动,确保高质量地完成工作,符合公司标准操作规程(SOP)、监管要求和合同义务。
主要职责:
- 监督日常临床运营,确保按照方案、SOP、ICH/GCP 和监管要求执行。
- 作为赞助商的主要运营联系人,提供更新信息,管理期望,并确保高质量地执行研究。
- 领导和支持临床研究助理(CRAs),包括培训、监督、绩效监督、联合监查以及监查访问报告的审核和批准。
- 通过主动审查监查活动、方案偏离、数据清单、招募进展和问题升级,确保机构和国家的表现。
- 确保研究文档的监督,包括 TMF 质量、CTMS 准确性、监查计划、培训计划和研究特定材料。
- 与项目经理协作进行研究规划、研究人员付款、资源分配、研究沟通和收入预测。
- 参与研究会议、研究者会议、可行性评估,并在需要时进行本地项目管理、CRA 支持和投标防御活动。
资格要求:
- 至少 5 年在 CRO、制药或生物技术环境中的临床监查经验。
- 至少 1 年作为临床研究经理(CRM)的经验,具备对机构和国家运营的明确监督经验。
- 至少 1 年眼科(OPH)经验,理想情况下在视网膜适应症如 DME、AMD、GA、RVO 或遗传性视网膜疾病(IRDs)领域。
- 需要英语和西班牙语流利。
- 对 ICH/GCP、监管要求和临床运营流程有深入理解。
- 具备领导 CRAs、管理研究交付物和…
查看英文原文
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
Join Our Team as a Clinical Research Manager (CRM) - home based in Argentina.
About this role
As part of our Ohtalmology team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.
The Clinical Research Manager (CRM) is responsible for coordinating and overseeing country and site management activities throughout study conduct, ensuring high‑quality delivery in accordance with company SOPs, regulatory requirements, and contractual obligations.
Key Responsibilities:
- Oversee day‑to‑day clinical operations to ensure delivery according to protocol, SOPs, ICH/GCP, and regulatory requirements.
- Serve as the primary operational contact for Sponsors, providing updates, managing expectations, and ensuring high‑quality study execution.
- Lead and support CRAs, including training, supervision, performance oversight, co‑monitoring, and review/approval of monitoring visit reports.
- Ensure site and country performance through proactive review of monitoring activities, protocol deviations, data listings, recruitment progress, and issue escalation.
- Maintain oversight of study documentation, including TMF quality, CTMS accuracy, monitoring plans, training plans, and study‑specific materials.
- Collaborate with the Project Manager on study planning, investigator payments, resource allocation, study communications, and revenue forecasting.
- Contribute to study meetings, Investigator Meetings, feasibility assessments, and, when required, local project management, CRA support, and bid defense activities.
Qualifications:
- Minimum 5 years of clinical monitoring experience in a CRO, pharmaceutical, or biotechnology environment.
- At least 1 year of experience as a Clinical Research Manager (CRM) with proven oversight of site and country operations.
- 1+ years of experience in Ophthalmology (OPH), ideally within retina indications such as DME, AMD, GA, RVO, or inherited retinal diseases (IRDs).
- Fluency in English and Spanish is required.
- Strong understanding of ICH/GCP, regulatory requirements, and clinical operations processes.
- Demonstrated ability to lead CRAs, manage study deliverables, and collaborate effectively with cross‑functional teams.
What We Offer
We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
A Bit More About Us
Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.
Together we make a difference.
Originally posted on Himalayas