Clinical Study Ops Lead - Remote-First

Beacon Biosignals; Boston (MA); Hybrid; USD 115,000 - 135,000; Full time

Job summary

Beacon Biosignals is seeking a Manager, Clinical Study Operations to lead a distributed ClinOps team. You will oversee feasibility, site start-up, enrollment, monitoring, and close-out, driving process standardization and data quality.

The role involves BD interactions, collaboration with Product, Engineering, Life Science, and BD teams, and coordinating with sponsors and CROs. You will bring 6+ years in clinical trial operations, a clinical/scientific degree, and hands-on experience with

Qualifications

• 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 in a fast-moving startup environment.

Responsibilities

• Lead ClinOps activities across studies your team runs — feasibility, site start-up, enrollment, monitoring, close-out.
• Set clear expectations, coach day-to-day execution, and elevate risks to leadership early.
• Own ClinOps KPIs and goals; track progress in project tools and report to leadership.
• Represent ClinOps in BD conversations, feasibility discussions, and Investigator Meetings.
• Manage day-to-day sponsor and CRO relationships, escalating decisions that require strategic alignment.

Skills

Clinical trial operations

People management

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree or higher in clinical/scientific field

Tools

CTMS/eTMF tooling

Regulatory SOPs

Job description

Beacon Biosignals is seeking a Manager, Clinical Study Operations to lead a distributed ClinOps team. You will oversee feasibility, site start-up, enrollment, monitoring, and close-out, driving process standardization and data quality.

The role involves BD interactions, collaboration with Product, Engineering, Life Science, and BD teams, and coordinating with sponsors and CROs. You will bring 6+ years in clinical trial operations, a clinical/scientific degree, and hands-on experience with