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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 lead a team within Clinical Study Operations (ClinOps), 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 coaching day-to-day execution of ClinOps activities across assigned studies
- Setting clear expectations, escalating risks to leadership proactively, and stepping in directly on complex or high-stakes situations
- Owning domain-level ClinOps goals and initiatives including process standardization, tooling improvements, and data quality
- Representing ClinOps in business development conversations, feasibility discussions, and Investigator Meetings
- Partnering closely with Product, Engineering, Life Science, and Business Development teams to keep trials on track and compliant
- Supporting team onboarding and ramp-up as the group grows
- Translating strategic priorities into a roadmap for your area with clear sequencing of initiatives and team growth
- Overseeing ClinOps KPIs and goals (execution timelines, enrollment metrics, data quality) and reporting progress to leadership
- Exercising sound judgment on issue classification and escalation, serving as the escalation point when reports are uncertain
- Leading domain-level ClinOps initiatives end-to-end (process standardization, tooling rollouts, dashboard improvements)
- Maintaining and improving ClinOps SOPs, work instructions, and CTMS practices
- Managing day-to-day relationships with sponsors and CRO intermediaries
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. Travel up to 15% is expected 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 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
- Comfortable ramping 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 ability to introduce appropriate process without unnecessary complexity
- Ability to travel up to 15% of the time
