远程工作雷达

临床研究运营经理

Clinical Study Operations Manager

职能支持全球可投
公司beaconbiosignals
薪资未公开
工作地点Boston, MA / Remote
地域资格全球可投
时区要求无特别要求
用工类型未标注
发布时间20 天前
数据来源Greenhouse
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全球可投:该职位未限制候选人所在地区。仍需注意薪资可能按地区折算,以及实际签约方式(正式雇佣 / 独立合同)。

Beacon Biosignals正在将精准医学应用于大脑领域,从临床开发到临床护理。对于生命科学合作伙伴,我们提供领先的居家脑电图(EEG)平台,用于新型治疗药物的临床开发,针对神经系统、精神疾病和睡眠障碍。我们的诊断业务正在构建最全面的居家诊断平台,结合脑电图和心肺信号,为睡眠和中枢神经系统疾病提供可报销的评估。我们正在改变患者被诊断和治疗的方式,无论其影响的是脑生理的何种疾病。

作为临床研究运营团队中的临床研究运营经理,您将负责确保Beacon临床研究的成功运营交付,从启动到结束。您将与赞助方、项目团队和临床机构密切合作,推动高效的研究执行,并坚持Beacon对质量、合规性和科学严谨性的承诺。

您将负责研究启动计划、机构入职和培训,以及持续的运营监督,以确保研究按时并按照最高标准执行。作为赞助方和内部团队的关键运营合作伙伴,您将主动识别风险,优化沟通,并在各利益相关方之间保持一致。此外,您还将通过指导同事遵守GCP规范、文档规范、版本控制和投诉管理,在组织内培养质量文化,提升团队整体的运营卓越性。

这是一项合同转正的个人贡献者职位,完全远程办公,可在全美任何地方工作,可能需要最多10%的出差。Beacon完善的异步工作实践确保了顶级的远程办公体验,但我们也在波士顿、纽约和巴黎设有线下办公室。

成功的表现包括:

  • 与项目团队合作,实施研究启动活动,包括沟通计划、物流、研究文件开发和数据配置。
  • 通过启动、维护和结束活动,让客户对研究运营建立信心。
  • 作为临床机构的主要联系人,确保运营顺畅和沟通清晰。
  • 为研究机构提供Beacon设备和研究方案使用的培训,确保设备正确使用和数据收集。
查看英文原文

Beacon Biosignals is transforming precision medicine for the brain, from clinical development to clinical care. For Life Sciences partners, we offer the leading at-home EEG platform for clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our Diagnostics business is building the most comprehensive at-home platform for precision diagnostics, combining EEG and cardiopulmonary signals to deliver reimbursable assessments for sleep and central nervous system disorders. Together, we're changing the way patients are diagnosed and treated for any disorder that affects brain physiology.

As a Clinical Study Operations Manager within the Clinical Study Operations team, you will be responsible for ensuring the successful operational delivery of Beacon’s clinical studies, from startup through close-out. You will work closely with sponsors, project teams, and clinical sites to drive efficient study execution and uphold Beacon’s commitment to quality, compliance, and scientific rigor.

You will oversee study startup planning, site onboarding and training, and ongoing operational oversight to ensure studies are executed on time and to the highest standards. Acting as a key operational partner to both sponsors and internal teams, you will proactively identify risks, streamline communication, and maintain alignment across stakeholders. In addition, you will foster a culture of quality within the organization by coaching peers on GCP compliance, documentation discipline, version control, and complaint management, strengthening the team’s collective operational excellence.

This is a contract-to-hire individual contributor role, fully remote anywhere in the U.S., and will require up to 10% travel. Beacon's robust asynchronous work practices ensure a first-class remote work experience, but we also have in-person office hubs available located in Boston, New York and Paris.

What success looks like:

  • Collaborate with project teams to implement study startup activities, including communication planning, logistics, development of study documentation, and data configuration.
  • Instill confidence with clients on study operations through start up, maintenance and close out activities.
  • Act as the primary point of contact for clinical sites, ensuring smooth operations and clear communication.
  • Provide training to research sites on the use of Beacon’s devices and study protocols, ensuring proper device usage and data collection.
  • Monitor project progress, ensuring adherence to timelines, protocols, and quality standards.
  • Maintain compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory standards.
  • Foster a culture of quality within the ClinOps and Scientific teams by coaching peers on GCP requirements, documentation discipline, versioning, and complaint management.
  • Address operational issues promptly, escalating through tools like Zendesk and Asana for resolution.
  • Provide actionable feedback from research sites to inform improvements in devices and workflows.

What you will bring:

  • 5+ years of experience in clinical project management or clinical operations roles.
  • Strong organizational and project management skills, with the ability to manage multiple responsibilities effectively.
  • Excellent written and verbal communication skills in English; additional languages are a bonus.
  • A proactive mindset with the ability to identify priorities and anticipate challenges.
  • Meticulous attention to detail, ensuring accuracy in data collection and reporting.
  • Ability to work in a fast paced environment with multiple priorities.
  • Familiarity with GCP, ICH guidelines, and clinical research regulatory requirements.
  • Knowledge of decentralized data collection, compliance and oversight while showing empathy for both patients and sites.
  • A desire to learn more about analytics, statistics, machine learning, and clinical trials.

The salary range for this role is $90,000 – $110,000. Salary ranges are determined using current market compensation data for this role and adjusted based on experience, skills, and location. The base salary is one component of the total compensation package, which includes equity, PTO and other benefits.

At Beacon, we've found that cultural and scientific impact is driven most by those that lead by example. As such, we're always seeking new contributors whose work demonstrates an avid curiosity, a bias towards simplicity, an eye for composability, a self-service mindset, and - most of all - a deep empathy towards colleagues, stakeholders, users, and patients. We believe a diverse team builds more robust systems and achieves higher impact.

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