Manager, Clinical Study Operations

Beacon Biosignals•Boston, MA

9d•$115,000 - $135,000•Remote

About The Position

Beacon Biosignals is seeking a Manager, Clinical Study Operations to lead a team within its Clinical Study Operations (ClinOps) group. ClinOps is responsible for end-to-end execution of internal and external device-based clinical trials, from feasibility and site start-up through recruitment, enrollment, data collection, monitoring, and close-out. The Manager will oversee ClinOps activities across studies run by direct reports, set clear expectations, coach day-to-day execution, escalate risks to leadership, and step in directly when needed. The role also owns and drives domain-level ClinOps goals and initiatives, including process standardization, tooling, and data quality. The Manager represents ClinOps in business development conversations, feasibility discussions, and Investigator Meetings, and partners with Product, Engineering, Life Science, and Business Development to keep trials on track and compliant. This position reports to the Director, Clinical Study Operations. The role requires hands-on clinical trial operations experience to guide team members through site and vendor issues, advise on day-to-day decisions, and directly manage complex or high-stakes situations. Beacon supports asynchronous work and a remote experience, with in-person hubs in Boston, New York, and Paris. The Clinical Study Operations group works across American and European time zones.

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 field.
At least 1–2 years of direct people-management experience, 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, including 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.
Experience working with CROs and vendors, including selection support, day-to-day oversight, and relationship management.
Strong cross-functional communication skills and ability to align Product, Engineering, and Data Science partners in a fast-paced startup environment.
Ability to work asynchronously across time zones in a remote-first, distributed organization.
Ability to introduce an appropriate level of process without unnecessary complexity.

Nice To Haves

Device-based clinical trial experience.
Experience with Qualio or similar QMS practices and systems.
Experience with proprietary CTMS/eTMF tooling; specific-tool experience is not required.

Responsibilities

Support onboarding and ramp-up for the growing team.
Translate Beacon’s strategic priorities into a roadmap for the Manager’s area, sequencing initiatives, process investment, and team growth, and communicate it to the manager and stakeholders.
Oversee ClinOps execution across direct reports’ studies, including feasibility, site start-up, enrollment, monitoring, and close-out; escalate risks and blockers early and explain available tradeoffs and options.
Own ClinOps KPIs and goals for the area, track progress in Asana, and report progress to leadership and cross-functional partners.
Make sound decisions about issue classification and escalation, including complaint versus technical-issue determinations and device reconciliation and invoicing decisions; serve as an escalation point for direct reports.
Lead ClinOps initiatives from scoping through delivery, such as process standardization, tooling rollouts, and dashboard or reporting improvements, partnering with Engineering, Product, and Data Science.
Maintain and improve ClinOps SOPs, work instructions, and CTMS practices, and drive continuous process improvement.
Represent ClinOps in advance of study execution in BD conversations, feasibility discussions, and Investigator Meetings, providing operational input to deal shaping, SOW discussions, and site and study planning.
Manage day-to-day working relationships with sponsors and, where applicable, CRO intermediaries for studies run by direct reports.
Represent Beacon directly with sponsors when a study lead escalates a decision requiring strategic alignment or sign-off.