Clinical Program Manager

Description

About EBR Systems

At EBR Systems, we're not imagining the future of cardiac care. We're building it. We are the team behind the world's first FDA-approved leadless left ventricular endocardial pacing device for heart failure. It's a breakthrough that's redefining what's possible, and it's just the beginning.

Based in Silicon Valley, we're advancing the WiSE System, a first-of-its-kind device in cardiac rhythm management. Your work here has a direct line to patients whose lives depend on what we build. We hire people who want to solve hard problems and who care about getting it right.

We invest in our people as much as our technology. Expect a collaborative, transparent culture, real career growth in a fast-moving startup, competitive compensation, equity, comprehensive benefits, and generous PTO.

If you want your work to matter, EBR is where you belong.

SUMMARY OF THE POSITION:

The Clinical Program Manager serves as a key operational partner to the Head of Clinical Affairs, helping lead the Clinical Affairs function at EBR Systems. This role owns the end-to-end execution of clinical programs supporting the WiSE System, including post-market studies, site start-up and management, and cross-functional coordination with Regulatory, Post Market Surveillance, Sales, and Field Clinical Engineering. The Clinical Program Manager builds and maintains dashboards and reporting tools that give leadership clear visibility into program status, site performance, and data quality, proactively identifies gaps that need to be addressed, and drives cross-functional teams to resolution. This individual represents Clinical Affairs across internal and, at times, external conversations, and supports Clinical Affairs Leadership as needed.

ESSENTIAL AND OTHER DUTIES AND RESPONSIBILITIES:

Essential Responsibilities:

• •Own the end-to-end execution of assigned clinical programs (e.g., WiSE-UP, SOLVE, and other clinical studies), including study start-up, site activation, timelines, budgets, and CRO/vendor coordination.
• •Build and maintain dashboards and reporting tools that give clinical and executive leadership clear, timely visibility into program status, site enrollment, data quality, and open action items, and support the use of real-world evidence (registries, EMR, claims data) to inform clinical and market access strategy.
• •Proactively identify gaps in data quality, site compliance, process, or team capacity, and drive them to resolution or escalate appropriately.
• •Lead and coordinate cross-functional teams (Clinical, Regulatory, Sales, Field Clinical Engineering, Marketing, Post Market Surveillance) to resolve open issues and keep programs on track.
• •Own the preparation and timely submission of periodic clinical study progress reports to the FDA (e.g., IDE/PAS annual reports), in coordination with Regulatory Affairs.
• •Manage site relationships and serve as a liaison to external stakeholders, including research sites, CROs, and regulatory bodies, monitoring site-level performance and compliance and addressing issues such as documentation gaps, missed reporting, or data quality concerns as they arise.
• •Develop and maintain SOPs, templates, and program documentation, and develop and deliver training for clinical research staff and site coordinators, to standardize execution and support protocol compliance and data quality.
• •Monitor study budgets and forecasts, identify variances, and partner with Clinical Affairs leadership and Finance to manage program spending.
• •Prepare regular program updates and executive-level summaries for leadership reviews and support preparation of Board-level clinical program updates as needed.
• •Develop, implement, and maintain clinical study protocols in accordance with Good Clinical Practice (GCP) guidelines and applicable regulatory requirements, and identify and proactively manage clinical program risks, escalating issues and driving mitigation plans as needed.
• •Ensure all clinical program activity is conducted in compliance with applicable FDA regulations, EBR Systems policies, and study protocols.

Other Responsibilities:

Other duties as assigned.

SUPERVISORY RESPONSIBILITIES:

This position may directly supervise Clinical Program Coordinators, study managers, and/or Clinical Research Associates, and provides guidance and direction to cross-functional contributors (Field Clinical Engineering, Regulatory, Sales, Post Market Surveillance) on clinical program deliverables. Carries out supervisory responsibilities in accordance with EBR Systems' policies and applicable laws, including participating in hiring and training, planning and assigning work, conducting performance reviews, and addressing and resolving problems.

QUALIFICATIONS:

Education and Required Experience:

• •Bachelor's degree in life sciences, biomedical engineering, nursing, or a related field required; advanced degree a plus.
• •7+ years of experience in medical device clinical affairs, clinical operations, or clinical program/project management, ideally within cardiovascular or cardiac rhythm management (CRM).
• •Demonstrated experience running clinical programs or studies end-to-end, including site start-up, timelines, budgets, and CRO/vendor coordination.
• •PMP certification a plus.
• •Working knowledge of Good Clinical Practice (GCP) guidelines, clinical research methodology, and applicable regulatory requirements.

Knowledge, Skills, and Abilities:

• •Working clinical/technical knowledge of cardiac implantable electronic devices (CIEDs) and CRM/electrophysiology concepts sufficient to engage credibly with physicians, field clinical engineers, and internal clinical staff.
• •Proven ability to build and maintain dashboards and reporting tools (Excel/Monday.com required; Zelta/Power BI/Sales Force a plus) that give leadership clear visibility into program status, enrollment, and data quality.
• •Strong cross-functional leadership skills; able to drive Clinical, Regulatory, Sales, Field Clinical Engineering, and Post Market Surveillance teams toward resolution on open issues.
• •Proactively identify gaps in data quality, site compliance, process, or team capacity, and drive them to resolution or escalate appropriately, ensuring closed-loop communication with internal partners and stakeholders so that issues are tracked to resolution and followed up on in a timely manner.
• •Excellent written and verbal communication skills; comfortable representing Clinical Affairs in cross-functional and external-facing settings.
• •Familiarity with FDA regulations and guidance relevant to clinical study conduct and unsolicited medical information requests (e.g., 21 CFR 812, unsolicited request guidance) a plus.
• •Proficiency with Microsoft Office (Excel, PowerPoint, Word) and clinical data tracking tools (i.e., Zelta, Monday.com).
• •Strong protocol development, technical writing, and data analysis skills, with attention to detail and sound risk management and quality assurance practices.
• •Ability to operationalize strategy into executable programs with clear milestones, monitor progress, and proactively manage and mitigate risk.
• •Familiarity with real-world evidence sources (registries, EMR, claims data) and their use in supporting clinical and market access strategy a plus.
• •Demonstrate flexibility and agility to take on additional projects and responsibilities as business needs evolve, adapting quickly to shifting priorities within Clinical Affairs.

PHYSICAL REQUIREMENTS:

• •Ability to travel up to 30% of the time.
• •Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms.
• •Required to stoop, kneel, bend, crouch and lift up to 20 pounds.
• •Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus.
• •Subject to extended periods of sitting and/or standing, vision to monitor, and moderate noise le