Note: The job is a remote job and is open to candidates in USA. EBR Systems, Inc. develops cardiac medical devices, including the WiSE System for cardiac rhythm management. The Clinical Program Manager leads end-to-end clinical program execution, manages sites and vendors, coordinates cross-functional teams, oversees reporting and compliance, and provides leadership with program visibility and risk mitigation.
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 duties as assigned
- 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
Skills
- 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, 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
- Can be an equivalent combination of education and professional experience
- 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
- 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
- Demonstrate flexibility and agility to take on additional projects and responsibilities as business needs evolve, adapting quickly to shifting priorities within Clinical Affairs
- 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 levels
- Advanced degree a plus
- PMP certification a plus
- 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
- Familiarity with real-world evidence sources (registries, EMR, claims data) and their use in supporting clinical and market access strategy a plus
Benefits
- 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
- 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
Company Overview