高级经理,临床研究运营
Senior Manager, Clinical Study Operations
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 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 EEG 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,无论其脑生理功能受到何种影响。
Beacon Biosignals 正在寻找一位临床研究运营经理,领导我们临床研究运营(ClinOps)团队中的一个小组。ClinOps 负责 Beacon 内部和外部基于设备的临床试验的全流程执行——从可行性评估和站点启动,到招募、入组、数据收集、监查和结题。
在此职位中,您将管理临床研究运营团队的直接下属,监督他们所负责研究的 ClinOps 活动——从可行性评估和站点启动,到数据收集、监查和结题。您需要设定明确的期望,指导日常执行,提前向领导层汇报风险以防止问题发生,并在研究需要时亲自介入。除了研究监督,您还将亲自负责并推动整个领域的 ClinOps 目标和计划——流程标准化、工具开发、数据质量等。您还需要在研究执行前代表 ClinOps 参与商务拓展对话、可行性讨论和研究者会议,并与产品、工程、生命科学和商务拓展团队紧密合作,确保试验按计划进行并保持合规。该职位向临床研究运营总监汇报。
您需要具备实际的临床试验运营经验——足以指导您的直接下属处理站点和供应商的问题,指导日常权衡决策,并在需要时亲自介入复杂或高风险的情况。
在 Beacon,文化和科学影响力来自于以身作则的领导者。我们寻找那些工作体现出好奇心、良好的判断力、对简单性的倾向、自助思维以及对同事、利益相关者、站点和患者的深刻同理心的合作者。我们认为多元化的团队能够构建更强大的系统并实现更高的影响力。
Beacon 的异步工作实践支持一种
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.
Beacon Biosignals is seeking a Manager, Clinical Study Operations to lead a team within our Clinical Study Operations (ClinOps) group. ClinOps is responsible for the end-to-end execution of Beacon's internal and external device-based clinical trials — from feasibility and site start-up through recruitment, enrollment, data collection, monitoring, and close-out.
In this role, you will manage a group of direct reports across Clinical Study Operations, overseeing the ClinOps activities on the studies they run — from feasibility and site start-up through data collection, monitoring, and close-out. You will set clear expectations, coach day-to-day execution, escalate risks to leadership before they become problems, and step in directly when a study needs it. Beyond study oversight, you will personally own and drive domain-level ClinOps goals and initiatives — process standardization, tooling, data quality — end to end. You will also represent ClinOps ahead of study execution — in BD conversations, feasibility discussions, and Investigator Meetings — and partner closely with Product, Engineering, Life Science, and BD to keep trials on track and compliant. This role reports to the Director, Clinical Study Operations.
You are expected to bring hands-on clinical trial operations experience — enough to guide your direct reports through site and vendor issues, coach sound day-to-day tradeoffs, and step in directly on complex or high-stakes situations when needed.
At Beacon, cultural and scientific impact comes from people who lead by example. We look for colleagues whose work reflects curiosity, sound judgment, a bias toward simplicity, a self-service mindset, and deep empathy for teammates, stakeholders, sites, and patients. We believe diverse teams build more robust systems and achieve higher impact.
Beacon's asynchronous work practices support a strong remote experience, with in-person hubs in Boston, New York, and Paris. The Clinical Study Operations group is distributed across American and European time zones.
What success looks like
- Support onboarding, and ramp-up for your team as it grows.
- Translate Beacon's strategic priorities into a roadmap for your area — sequencing initiatives, process investment, and team growth — and communicate it clearly to your manager and other stakeholders.
- Oversee ClinOps execution across the studies your direct reports run — feasibility, site start-up, enrollment, monitoring, close-out — and escalate risks and blockers to leadership early, with a clear read on tradeoffs and options.
- Own ClinOps KPIs and goals for your area (execution timelines, enrollment and data quality metrics…), track progress in Asana, and report clearly to leadership and cross-functional partners.
- Exercise sound judgment on issue classification and escalation — including complaint vs. technical-issue calls and device reconciliation/invoicing decisions — stepping in as the escalation point when your reports are uncertain how to proceed.
- Lead domain-level ClinOps initiatives end to end — e.g., process standardization, tooling rollouts, dashboard/reporting improvements — scoping the work, driving it with Engineering, Product, and Data Science partners, and owning the outcome yourself.
- Maintain and improve ClinOps SOPs, work instructions, and CTMS practices within your area, and drive continuous process improvement.
- Represent ClinOps ahead of study execution — in BD conversations, feasibility discussions, and Investigator Meetings — bringing operational expertise to deal shaping, SOW input, and site/study planning before work kicks off. This representation is operational and tactical in nature — bringing feasibility and execution input into deal shaping and SOW discussions — rather than strategic decision-making authority over deal terms.
- Manage Beacon's day-to-day working relationship with sponsors — and, where applicable, a CRO intermediary — on the studies your direct reports run, and step in to represent Beacon directly with the sponsor when a study lead escalates a decision that needs strategic alignment or sign-off.
What you will bring
- 6+ years of experience in clinical trial operations in biotech, medtech, or pharma (device-based trial experience a strong plus).
- Bachelor's or advanced degree in a clinical or scientific field.
- 1-2+ years directly managing people, with a track record of hiring, coaching, and performance management.
- Ability to travel up to 15% of the time for Investigator Meetings, sponsor engagements, and site visits.
- Demonstrated ownership of the clinical trial lifecycle: start-up, recruitment strategy, enrollment, monitoring, data cleaning, and close-out.
- Working knowledge of GCP, FDA and global regulatory requirements, and experience with SOP development and QMS practices (Qualio or similar).
- Comfortable ramping up quickly on proprietary CTMS/eTMF tooling (e.g., internal study configuration platforms, eBinder systems, LMS) in a fast-moving startup environment — prior specific-tool experience not required.
- Experience working with CROs and vendors: selection support, day-to-day oversight, and relationship management.
- Strong cross-functional communication skills, with the ability to align Product, Engineering, and Data Science partners in a fast-paced startup environment.
- Comfortable operating asynchronously across time zones in a remote-first, distributed organization.
- A bias toward simplicity — able to introduce the right level of process without adding unnecessary complexity.
The salary range for this role is $115,000 – $135,000. 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.