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Manager, Clinical Study Operations

Beacon Biosignals - Boston, MA, United States - Hybrid - posted 2026-10-15

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Salary: USD 115,000 - 135,000 / annual

Beacon Biosignals is transforming precision medicine for the brain through at-home EEG platforms for clinical development and diagnostics. The company combines EEG and cardiopulmonary signals to deliver reimbursable assessments for sleep and central nervous system disorders. You will manage a team within the Clinical Study Operations (ClinOps) group, overseeing end-to-end execution of device-based clinical trials from feasibility and site start-up through recruitment, enrollment, data collection, monitoring, and close-out. Your responsibilities include: - Managing direct reports and setting clear expectations for day-to-day ClinOps execution across assigned studies - Coaching your team through site and vendor issues, complex tradeoffs, and high-stakes situations - Escalating risks to leadership early, with clear analysis of tradeoffs and options - Owning ClinOps KPIs and goals (execution timelines, enrollment metrics, data quality), tracking progress in Asana, and reporting to leadership - Leading domain-level ClinOps initiatives end-to-end: process standardization, tooling rollouts, dashboard improvements, SOP development, and continuous process improvement - Representing ClinOps in business development conversations, feasibility discussions, and Investigator Meetings, bringing operational expertise to deal shaping and SOW input - Managing day-to-day relationships with sponsors and CRO intermediaries, stepping in to represent Beacon when strategic alignment is needed - Exercising sound judgment on issue classification, escalation, and operational decisions (complaint vs. technical issues, device reconciliation, invoicing) - Supporting team onboarding and ramp-up as the group grows - Translating Beacon's strategic priorities into a roadmap for your area, sequencing initiatives and team growth Beacon operates with asynchronous work practices supporting remote work, with in-person hubs in Boston, New York, and Paris. The ClinOps group is distributed across American and European time zones. You may travel up to 15% of the time for Investigator Meetings, sponsor engagements, and site visits. REQUIREMENTS: - 6+ years of experience in clinical trial operations in biotech, medtech, or pharma (device-based trial experience strongly preferred) - 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 - Demonstrated ownership of the full 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) - Experience working with CROs and vendors: selection support, day-to-day oversight, and relationship management - Ability to ramp up quickly on proprietary CTMS/eTMF tooling (e.g., internal study configuration platforms, eBinder systems, LMS) in a fast-moving startup environment - Strong cross-functional communication skills, with ability to align Product, Engineering, and Data Science partners - Comfortable operating asynchronously across time zones in a remote-first, distributed organization - Bias toward simplicity and sound judgment in process design - Ability to travel up to 15% of the time

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