Beacon Biosignals
Beacon Biosignals
Beacon Biosignals develops EEG-based neurobiomarkers for precision medicine in neurology and psychiatry. Its platform records brain activity in real time and applies machine learning to help clinical researchers evaluate treatment response, guide dose selection, and identify relevant patient populations. The company works with biopharmaceutical companies, academic medical centers, and neurotechnology developers seeking better tools for neurological and psychiatric drug development, diagnosis, and care.

Clinical Study Operations Manager, Massachusetts Remote

Lead clinical study operations and device-based clinical trials at Beacon Biosignals, a brain precision-medicine company. Oversee study execution, compliance, performance metrics, sponsor relationships, and Clinical Operations initiatives.

Description

  • Support onboarding and ramp-up for the Clinical Study Operations team
  • Turn strategic priorities into an area roadmap covering initiative sequencing, process investment, and team growth
  • Oversee Clinical Operations across feasibility, site start-up, enrollment, monitoring, and close-out
  • Escalate risks and blockers to leadership with clear tradeoffs and response options
  • Own Clinical Operations KPIs and goals, track progress in Asana, and report to leadership and cross-functional partners
  • Make issue classification and escalation decisions, including complaint versus technical-issue determinations and device reconciliation or invoicing decisions
  • Lead Clinical Operations initiatives such as process standardization, tooling rollouts, and dashboard or reporting improvements
  • Maintain and improve Clinical Operations SOPs, work instructions, and CTMS practices
  • Represent Clinical Operations in business development discussions, feasibility reviews, and Investigator Meetings
  • Manage working relationships with sponsors and CRO intermediaries, representing Beacon when escalated decisions require alignment or sign-off
  • Partner with Product, Engineering, Life Science, Data Science, and Business Development to keep trials on track and compliant

Requirements

  • At least 6 years of clinical trial operations experience in biotech, medtech, or pharma
  • Bachelor’s or advanced degree in a clinical or scientific discipline
  • At least 1–2 years of direct people management experience, including hiring, coaching, and performance management
  • Willingness to travel up to 15% for Investigator Meetings, sponsor engagements, and site visits
  • Demonstrated ownership of the clinical trial lifecycle, including start-up, recruitment strategy, enrollment, monitoring, data cleaning, and close-out
  • Working knowledge of GCP and FDA and global regulatory requirements
  • Experience developing SOPs and applying QMS practices, using Qualio or a similar system
  • Ability to quickly learn proprietary CTMS and eTMF tools; experience with a specific system is not required
  • Experience supporting CRO and vendor selection, day-to-day oversight, and relationship management
  • Strong cross-functional communication skills
  • Ability to work asynchronously across time zones in a remote-first, distributed organization
  • A practical approach to process design, with a focus on adding only the level of structure needed

Benefits

  • Equity
  • Paid time off
  • Asynchronous work practices designed to support a strong remote experience
  • In-person hubs in Boston, New York, and Paris
  • Remote-first, distributed organization

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