Senior ClinOps Manager — Remote & Cross-Functional Trials

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

Job summary

Beacon Biosignals is seeking a Manager, Clinical Study Operations to lead a team across ClinOps, overseeing feasibility, site start-up through data close-out for device-based trials. You will guide day-to-day execution, escalate risks, and drive domain-level goals, including process standardization and data quality.

You will partner with Product, Engineering, Life Science, and BD to keep trials on track and compliant.

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 (e.g., internal study configuration platforms, eBinder systems, LMS) in a fast-moving startup environment — 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, with the ability to align Product, Engineering, and Data Science partners in a fast-paced startup environment.
• 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.

Responsibilities

• Support onboarding, and ramp-up for your team as it grows.
• Translate Beacon's strategic priorities into a roadmap for your area — sequencing initiatives, process investment, and team growth — and communicate it clearly to your manager and other stakeholders.
• Oversee ClinOps execution across the studies your direct reports run — feasibility, site start-up, enrollment, monitoring, close-out — and elevate risks and blockers to leadership early, with a clear read on tradeoffs and options.
• Own ClinOps KPIs and goals for your area (execution timelines, enrollment and data quality metrics…), track progress in Asana, and report clearly to leadership and cross-functional partners.
• Exercise sound judgment on issue classification and escalation — including complaint vs. technical-issue calls and device reconciliation/invoicing decisions — stepping in as the escalation point when your reports are uncertain how to proceed.
• Lead domain-level ClinOps initiatives end to end — e.g., process standardization, tooling rollouts, dashboard/reporting improvements — scoping the work, driving it with Engineering, Product and Data Science partners, and owning the outcome yourself.
• Maintain and improve ClinOps SOPs, work instructions and CTMS practices within your area, and drive continuous process improvement.
• Represent ClinOps ahead of study execution — in BD conversations, feasibility discussions and Investigator Meetings — bringing operational expertise to deal shaping, SOW input, and site/study planning before work kicks off. This representation is operational and tactical in nature — bringing feasibility and execution input into deal shaping and SOW discussions — rather than strategic decision-making authority over deal terms.
• Manage Beacon's day-to-day working relationship with sponsors — and, where applicable, a CRO intermediary — on the studies your direct reports run, and step in to represent Beacon directly with the sponsor when a study lead escalates a decision that needs strategic alignment or sign-off.

Skills

Clinical trial operations

People management

GCP & regulatory knowledge

CTMS/eTMF tooling

Vendor management

Cross-functional collaboration

Travel readiness

Remote work adaptability

SOP/QMS familiarity

Data integrity & quality

Education

Bachelor's degree in clinical or scientific field

Tools

Qualio (or similar)

CTMS/eTMF platforms

Job description

Beacon Biosignals is seeking a Manager, Clinical Study Operations to lead a team across ClinOps, overseeing feasibility, site start-up through data close-out for device-based trials. You will guide day-to-day execution, escalate risks, and drive domain-level goals, including process standardization and data quality.

You will partner with Product, Engineering, Life Science, and BD to keep trials on track and compliant.