Clinical Program Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $155k - $175k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🏥 Clinical Operations

👻 Ghost score 0%

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EBR Systems, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏭 Manufacturing

🏥 Healthcare

🧬 Biotechnology

Manufacturing • Healthcare • Biotechnology

EBR Systems, Inc. is driven to deliver superior treatment for millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective, and reliable therapies using wireless cardiac stimulation. The company’s initial product, the WiSE® CRT System, is a first-of-its-kind medical device developed to overcome the limitations of traditional Cardiac Resynchronization Therapy (CRT) in heart failure patients by eliminating the need for a lead to the heart’s left ventricle and the associated complications of that lead.

📋 Description

• Serve as a key operational partner to the Head of Clinical Affairs • Own end-to-end execution of assigned clinical programs, including WiSE-UP, SOLVE, and other clinical studies • Manage study start-up, site activation, timelines, budgets, and CRO/vendor coordination • Build and maintain dashboards and reporting tools for program status, site enrollment, data quality, and open action items • Support use of real-world evidence from registries, EMR, and claims data • Identify gaps in data quality, site compliance, processes, or team capacity and drive them to resolution • Lead cross-functional teams across Clinical, Regulatory, Sales, Field Clinical Engineering, Marketing, and Post Market Surveillance • Prepare and submit periodic clinical study progress reports to the FDA in coordination with Regulatory Affairs • Manage site relationships and liaise with research sites, CROs, and regulatory bodies • Monitor site performance and compliance and address documentation, reporting, and data quality issues • Develop and maintain SOPs, templates, and program documentation • Develop and deliver training for clinical research staff and site coordinators • Monitor study budgets and forecasts, identify variances, and manage program spending with Finance • Prepare program updates, executive summaries, and Board-level clinical program updates • Develop, implement, and maintain clinical study protocols according to GCP and regulatory requirements • Identify and manage clinical program risks, escalation, and mitigation plans • Ensure compliance with FDA regulations, EBR Systems policies, and study protocols • Supervise Clinical Program Coordinators, study managers, and/or Clinical Research Associates as assigned • Participate in hiring, training, work planning, performance reviews, and problem resolution

🎯 Requirements

• Bachelor's degree in life sciences, biomedical engineering, nursing, or a related field required • 7+ years of experience in medical device clinical affairs, clinical operations, or clinical program/project management • Experience 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 • Working knowledge of Good Clinical Practice (GCP) guidelines, clinical research methodology, and applicable regulatory requirements • Working clinical/technical knowledge of cardiac implantable electronic devices (CIEDs) and CRM/electrophysiology concepts • Proven ability to build and maintain dashboards and reporting tools; Excel and Monday.com required • Strong cross-functional leadership skills • Excellent written and verbal communication skills • Proficiency with Microsoft Office (Excel, PowerPoint, Word) and clinical data tracking tools • Strong protocol development, technical writing, and data analysis skills • Attention to detail and sound risk management and quality assurance practices • Ability to operationalize strategy into executable programs with clear milestones • Familiarity with FDA regulations and guidance relevant to clinical study conduct • Ability to travel up to 30% of the time • Ability to lift up to 20 pounds • PMP certification a plus • Familiarity with Zelta, Power BI, and Salesforce a plus • Familiarity with real-world evidence sources a plus

🏖️ Benefits

• Competitive compensation • Equity • Comprehensive benefits • Generous PTO • Medical, dental, and vision insurance provided at no cost for employee-only coverage • 401(k) matching plan • Paid Time Off – starting at 3 weeks per year • Competitive salary with opportunities for career growth • Employee stock options • Life & AD&D and long term disability insurance • Education assistance • Voluntary commuter benefits and pet insurance • Weekly company lunches and occasional happy hour events • Meaningful work and growth opportunities