Clinical Program Manager
About The Position
Sonus Microsystems is reimagining ultrasound for continuous, operator-independent patient monitoring, and we're looking for a Clinical & Program Operations Manager to join our highly collaborative team of scientists, engineers, and innovators working at the intersection of deep tech and real-world clinical impact. You will contribute to a pivotal stage of the company, where the work you do will help shape the technology, the product, and ultimately the experience of patients and healthcare providers around the world. This is an opportunity to take ownership of the clinical programs that will help move Sonus’ breakthrough Ultrasound AI platform from development into clinical practice. Working directly with the CEO and operations leadership, you will become the operational owner across our clinical studies and clinical programs, ensuring they are thoughtfully planned, effectively coordinated and successfully delivered. As the first dedicated hire in this function, you will have the opportunity to help define how clinical programs operate at Sonus, while remaining deeply involved in the day-to-day execution that drives them forward. You will directly influence product design and functionality to optimize outcomes for both clinical trials and end-user clinicians. You will thrive in this role if you are someone who is hands-on, takes ownership, enjoys solving complex operational challenges, and wants to play a defining role in how Sonus delivers its clinical programs as the company grows.
Requirements
- A strong foundation in clinical trial operations across multiple studies or programs, including study start-up, feasibility, site selection, activation, IRB submissions, clinical documentation and reporting
- A background in medical devices, or other regulated healthcare environment, with an understanding of the regulatory and quality requirements that shape clinical studies
- Proven stakeholder management capabilities, from internal technical teams through external investigators, KOLs, clinical sites and strategic partners
- Experience preparing program status materials and supporting leadership updates
- A hands-on approach, moving confidently between detailed execution and broader program oversight
Nice To Haves
- History of contributing clinical sections to regulatory submissions (510(k), De Novo, IDE or equivalent)
- Experience with milestone reporting for large grants and multi-stakeholder programs
- Sound judgement around priorities, dependencies and risk, with the confidence to surface issues before they become problems
- Adaptable and proactive, with a genuine enthusiasm for the dynamic, hands-on environment of a growing startup
Responsibilities
- Build robust processes for tracking milestones and deliverables across multiple clinical programs
- Identify dependencies, schedule risks and potential delays, proactively resolving or escalating issues before they impact key milestones
- Prepare program status updates and milestone reporting for leadership and strategic partners
- Lead feasibility assessments, site selection and KOL engagement to support successful study planning
- Prepare, support and submit IRB applications and essential study documentation required for study start-up
- Act as clinical coordinator, ensuring documentation, approvals and timelines remain aligned throughout execution
- Ensure seamless clinical study execution by identifying performance insights and working cross-functionally to implement rapid, effective improvements
- Serve as the day-to-day operational contact for investigators, clinical sites, KOLs and external partners
- Partner with engineering, regulatory and quality teams to ensure clinical activities remain aligned with technical and regulatory requirements
- Support FDA and Health Canada submissions by compiling, organizing and quality-checking the clinical documentation and study data that feed them, working alongside our regulatory consultants
- Maintain clinical documentation in an inspection-ready state, consistent with our quality system and applicable standards
- Ensure clinical activities and records align with design control and regulatory requirements
Benefits
- Meaningful stock options in an early-stage company with institutional backing
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
