RTSM Specialist
职位标题：RTSM 专家工作地点：虚拟阿根廷工作地址类型：远程工作合同类型：全日制工作资深级别：我们是谁 我们是一个全球中大型的 CRO,超越界限，创新和发明，因为世界上最持久的疾病的治疗路由不由那些玩得安全的人铺平。它是由那些采取先，创造性方法并以质量和卓越的方式实施者构建的。我们是世界范围内的临床试验，我们是一支拥有超过3,500+名专家，聪明思想家，梦想家和行为者的全球团队，共同改变了世界 CROs 的体验方式。我们的使命是每天以热情和目的努力改善生活，我们正在寻找那些重视同样的追求的人。为什么全球 我们相信每个人都在为患者及其护理人员带来变化方面发挥重要作用。从我们的实践可靠领导者到我们的团队，我们致力于让来自不同背景和经验的专业人士取得成功。我们优先培养多元化的包容环境，继续促进合作和创造力。我们自豪地成为一个通过自我发展而成长并受到鼓舞的工作场所。加入我们！临床系统部门在全球范围内所做的事情 我们的临床系统部对整个组织发挥着重要作用，通过确保我们的系统能够开发出用于研究规格，完全集成，运行最佳和全过程中保持良好。该部门与行业特定系统 （如：IRT,RTSM,EDC,RBQM Opra,ClinSpark,eTMF 和 CTMS）密切合作。该部门具有各种角色，包括面向客户项目经理，系统和软件设计师以及实施和验证专家。这些领域中的每个提供导师和培训。在与各种系统合作时，该部门内部取得了成功的记录。你将要做的事情 任务可能包括但不限于：• 从授予到 RTSM 退役期间提供项目管理监督，包括对交付成果和时间表的监督和问责以及完成工作按照全球 SOP 标准。•向利益相关者传达有关适用的 RTSM 项目的活动信息，包括内部和赞助团队。作为接触升级点。
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Job Title: RTSM Specialist
Job Location: Virtual Argentina
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What the Clinical Systems department does at Worldwide
Our Clinical Systems Department plays an essential role for the entire organization by ensuring our systems are developed to study specifications, fully integrated, optimally running, and well-maintained throughout the studies’ lifecycle. The department works closely with industry-specific systems such as: IRT, RTSM, EDC, RBQM Opra, ClinSpark, eTMF, and CTMS. The department has various roles, including client-facing Project Managers, System and Software Designers, and Implementation and Validation specialists. Each of these areas provides mentorship and training. In working with a variety of systems, the department has a proven record of success for promotions and growth internally.
What you will do
Tasks may include but are not limited to:
• Provide project management oversight from award to RTSM decommissioning, including oversight and accountability of deliverables and timelines and completion of work to Worldwide SOP standards
• Communicates information on applicable RTSM project activities to stakeholders, including internal and sponsor study teams. Serves as the escalation point of contact for all RTSM assigned study-related project issues
• Overall accountability for coordination and timely delivery of RTSM project communications, including study status reports, meeting agendas and minutes, and scheduling project calls
• Willingness to travel and attend Investigator Meetings or other types of project-related meetings when required
• Responsible for overall RTSM project budget and ensuring accurate vendor work orders for assigned studies
• Responsible for overall RTSM study design, as well as writing or reviewing and approving User Requirements Specification (URS)
• Prepare, review and approve site and support materials as well as helpdesk documentation, when required
• Perform financial review and budget management, including review of Change Orders
• Perform QC checks of manual database edits and other tasks where required
• Request, receive and process/upload draft and final subject and kit schedules and inventory release files where required
• Create User Acceptance Test plans and complete user acceptance testing
• Facilitate sponsor completion of user acceptance testing of system
• Accountability for monitoring study randomization to ensure correct execution
• Perform other duties as assigned
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
What you will bring to the role
- Ability to communicate concisely and effectively in both written and spoken English.
• Proficient client-facing skills
- Proficient in the use of common office software
- • Self-motivated individual who can positively contribute to a team environment
- • High attention to detail
- • Ability to prioritize and handle multiple projects simultaneously
- • Able to make effective decisions in a fast-paced, highly dynamic environment
- • Able to be creative, adapt to new technologies, concepts and processes, make improvements and solve problems.
Your experience
- Educated to degree level in a relevant discipline or able to demonstrate equivalent experience
• Minimum 2 years prior RTSM experience
- Minimum 1 year prior project management experience
- • Minimum of 2 years' experience within CRO /pharma environment
- • Contract Research Organization (CRO) or Pharmaceutical experience required
- • Familiar with RTSM topics, including RTSM study design, randomization methodologies, and just-in-time drug supply
- • Understanding of clinical trials, blinding, patient safety, data integrity, and associated regulations
- • Proven ability to manage delivery of RTSM solutions deployed in clinical trials
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
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Originally posted on Himalayas