Manager - Clinical Study Operations

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.