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中央监控员 II(RBQM/KRI 审核经验)

Central Monitor II (RBQM / KRI review Exp)

职能支持限定地区(需当地身份)
公司Syneos Health India Private Limited
薪资未公开
工作地点India
地域资格限定地区(需当地身份)
时区要求日间重叠约 6 小时,基本正常作息
用工类型Full Time
发布时间14 天前
数据来源Himalayas
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注意地域限制:该职位明确限定在 India 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。

Central Monitor II(RBQM / KRI审查经验)
Syneos Health® 是一家领先的全集成生命科学服务组织,旨在加速客户成功。我们与药物开发和商业化流程中每个环节的创新者合作,帮助他们应对复杂性、预见变化并加快进展。

我们的临床解决方案团队成员以药物开发思维行事,运用多年的经验和专业知识,真正理解客户需求,并在我们打造的解决方案中代表这些需求。

无论您加入我们作为功能服务提供商合作伙伴还是全服务环境中的成员,您都将与充满热情的问题解决者合作,作为团队共同创新,帮助我们的客户实现目标。我们敏捷且注重成果——为彼此、我们的客户,以及最重要的是,为有需要的人。

了解您的25,000名未来同事已经知道的内容:
为什么选择 Syneos Health
• 我们致力于通过职业发展和晋升、支持性的直线管理、技术和治疗领域培训、同行认可和全面福利计划来培养员工。
• 我们致力于打造包容的文化——在这里你可以真实地做自己。这与我们的使命紧密相关——Driven to Deliver(致力于交付),体现了我们员工每天展现的热情,塑造能够显著影响他人生活的解决方案。
• 我们不断打造我们所有人都希望工作的公司,也是客户希望与之合作的公司。为什么?因为我们知道,当我们将来自世界各地的聪明人才聚集在一起时,我们可以塑造医疗健康的未来,为客户带来影响,并定义患者进展的速度。

职位职责

  • 至少具备2年的相关CM经验
  • 愿意大量参与RBQM驱动的流程
  • 有KRIs审查经验者优先
  • 需要适应EMEA时区
  • 有Cluepoints经验者优先
  • 协助Central Monitoring Lead完成用于集中监查的数据分析工具的特定研究设置和持续维护
  • 作为RBM数据分析工具专家,负责数据风险审查、风险和问题管理
  • 参与对中央和本地研究团队的RBQM和集中监查流程培训
  • 执行研究数据的集中监查,并根据研究监查计划维护研究/国家/站点的风险参数
查看英文原文

Central Monitor II (RBQM / KRI review Exp)Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:
Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities

  • Should have minimum 2yrs of relevant CM experience
  • Willing to work extensively in RBQM‑driven processes.
  • Experience in reviewing KRIs preferred
  • EMEA timing
  • Cluepoints Experience preferable
  • Supports the Central Monitoring Lead in the study-specific set-up and ongoing maintenance of the data analytical tool used for centralized monitoring
  • RBM data analytical tool expert for conducting data risk review, risk and issue management
  • Participates in the training of central and local study teams on RBQM and central monitoring processes
  • Performs centralized monitoring of study data and maintains oversight of study/country/site risk parameters according to the study monitoring plan
  • Identifies data quality trends indicative of systematic errors and potential study/country/site performance issues
  • Communicates to relevant study team members trends/findings, implications and recommends actions within data analytical tool and provides regular status reports to study team
  • Ensures the proper documentation & archiving of instream data reviews, risk and issue management
  • Shares the responsibility for data quality at the study, country and site levels

Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Originally posted on Himalayas

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