Manager, Clinical Study Operations
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Job Description
Clinical Study Operations Manager leading teams and device-based clinical trials at Beacon Biosignals, a brain precision-medicine company. Overseeing study execution, compliance, KPIs, sponsors, and ClinOps initiatives.
Responsibilities:
- Support onboarding and ramp-up for the Clinical Study Operations team
- Translate strategic priorities into a roadmap for the area, including initiative sequencing, process investment, and team growth
- Oversee ClinOps execution across feasibility, site start-up, enrollment, monitoring, and close-out
- Escalate risks and blockers to leadership with clear tradeoffs and options
- Own ClinOps 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 calls and device reconciliation/invoicing decisions
- Lead domain-level ClinOps initiatives such as process standardization, tooling rollouts, and dashboard/reporting improvements
- Maintain and improve ClinOps SOPs, work instructions, and CTMS practices
- Represent ClinOps in BD conversations, feasibility discussions, and Investigator Meetings
- Manage working relationships with sponsors and CRO intermediaries; represent Beacon directly when escalated decisions require alignment or sign-off
- Partner with Product, Engineering, Life Science, Data Science, and BD to keep trials on track and compliant
Requirements:
- 6+ years of experience in clinical trial operations in biotech, medtech, or pharma
- 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
- Experience with SOP development and QMS practices (Qualio or similar)
- Comfortable ramping up quickly on proprietary CTMS/eTMF tooling; 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
- 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
Benefits:
- Equity
- PTO
- Asynchronous work practices supporting a strong remote experience
- In-person hubs in Boston, New York, and Paris
- Remote-first, distributed organization
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