Manager, Clinical Study Operations

Beacon Biosignals; Boston (MA); Hybrid; USD 115,000 - 135,000; Full time

Job summary

Beacon Biosignals is seeking a Manager, Clinical Study Operations to lead a distributed ClinOps team. You will oversee feasibility, site start-up, enrollment, monitoring, and close-out, driving process standardization and data quality.

The role involves BD interactions, collaboration with Product, Engineering, Life Science, and BD teams, and coordinating with sponsors and CROs. You will bring 6+ years in clinical trial operations, a clinical/scientific degree, and hands-on experience with

Qualifications

• 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 in a fast-moving startup environment.

Responsibilities

• Lead ClinOps activities across studies your team runs — feasibility, site start-up, enrollment, monitoring, close-out.
• Set clear expectations, coach day-to-day execution, and elevate risks to leadership early.
• Own ClinOps KPIs and goals; track progress in project tools and report to leadership.
• Represent ClinOps in BD conversations, feasibility discussions, and Investigator Meetings.
• Manage day-to-day sponsor and CRO relationships, escalating decisions that require strategic alignment.

Skills

Clinical trial operations

People management

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree or higher in clinical/scientific field

Tools

CTMS/eTMF tooling

Regulatory SOPs

Job description

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, elevate 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 elevate 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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Beacon Biosignals’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

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A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

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An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.