Clinical Applications Analyst/Planner & Coordinator
Role details
Job location
Tech stack
Job description
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As a Clinical Applications Analyst/Planner & Coordinator, you will serve as the operational backbone of our mitral valve replacement studies, working across physician training, case planning, and site logistics. The role is fast-paced and evolving, requiring excellent organizational and project management skills, with the ability to travel to sites domestically and internationally.
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Plan and execute international and domestic case support and physician training across investigational sites, coordinating scheduling, facility logistics and reservations, device demonstrations, and simulation labs
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Manage patient screening pipeline of incoming patient echo, CT, medical history, imaging downloads, internal screening team reviews, and external screening committee reviews.
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Assemble, maintain, and manage logistics for physician training kits and device demonstration kits.
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Create or manage digital resources and tools for patient screening, such as Clario, and manage controlled documentation in documentation systems, such as Propel.
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Track training completion, document attestations, and maintain training records in the Trial Master File (TMF)
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Partner with site research coordinators, hospital staff, local 3PLs, service engineering, to create a site case plan and communicate planning to internal and external stakeholders, which include physicians, hospital staff, case support team, and leadership.
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Collaborate with clinical affairs to ensure baseline screening/eligibility data quality and completeness in electronic data capture (EDC) system
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Oversee device and supply logistics to clinical sites, ensuring accurate inventory, timely shipment, and accountability documentation
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Analyze data to create metric reports on trial screening and patient pipeline.
Requirements
Do you have experience in Stakeholder management?, Do you have a Bachelor's degree?, * Exceptional multi-stakeholder coordination and project management in fast-paced, high-consequence environments
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Meticulous documentation and record-keeping habits; comfort with SOPs, trackers, and structured reporting
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Comfort with data analysis or operational metrics
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Strong interpersonal and communication skills across diverse audiences, from frontline site staff to physicians and executive sponsors
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Experience planning and executing complex, time-sensitive programs or events with multiple concurrent workstreams
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Comfort with rapid context-switching and managing competing priorities under pressure, * Bachelor's Degree in biological sciences or a lifesciences field or hospitality.
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3+ years of operations, project coordination, or program management experience; backgrounds in hospitality operations, healthcare, CRO, or regulated industry environments are all welcome
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Prior exposure to clinical research, medical device operations, or a hospital/health system environment is a strong plus - not a requirement at hire
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Familiarity with project tracking tools (Smartsheet, Asana, Monday.com) and/or EDC platforms (Castor) preferred
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Ability to work onsite in Santa Cruz as needed
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Ability to travel up to 20% of the time with overnight stays
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Ability to work outside the Monday-Friday, 9am-5pm schedule as needed to support cases and site activities across time zones
Benefits & conditions
Pulled from the full job description
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Health insurance
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Vision insurance
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Dental insurance, * We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space that can make a meaningful impact for patients
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We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off
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We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you'd like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!