Clinical Case Planning & Operations Specialist

Description:

• As a Clinical Case Planning & Operations Specialist, 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. 

• 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 

• Manage patient screening pipeline of incoming patient echo, CT, medical history, imaging downloads, internal screening team reviews, and external screening committee reviews. 

• Assemble, maintain, and manage logistics for physician training kits and device demonstration kits. 

• Create or manage digital resources and tools for patient screening, such as Clario, and manage controlled documentation in documentation systems, such as Propel. 

• Track training completion, document attestations, and maintain training records in the Trial Master File (TMF) 

• 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. 

• Collaborate with clinical affairs to ensure baseline screening/eligibility data quality and completeness in electronic data capture (EDC) system 

• Oversee device and supply logistics to clinical sites, ensuring accurate inventory, timely shipment, and accountability documentation 

• Analyze data to create metric reports on trial screening and patient pipeline. 

Skills:

• Exceptional multi-stakeholder coordination and project management in fast-paced, high-consequence environments 

• Meticulous documentation and record-keeping habits; comfort with SOPs, trackers, and structured reporting 

• Comfort with data analysis or operational metrics 

• Strong interpersonal and communication skills across diverse audiences, from frontline site staff to physicians and executive sponsors 

• Experience planning and executing complex, time-sensitive programs or events with multiple concurrent workstreams 

• Comfort with rapid context-switching and managing competing priorities under pressure 

Requirements:

• Bachelor’s Degree in biological sciences or a lifesciences field or hospitality.  

• 3+ years of operations, project coordination, or program management experience; backgrounds in hospitality operations, healthcare, CRO, or regulated industry environments are all welcome 

• Prior exposure to clinical research, medical device operations, or a hospital/health system environment is a strong plus — not a requirement at hire 

• Familiarity with project tracking tools (Smartsheet, Asana, Monday.com) and/or EDC platforms (Castor) preferred 

• Ability to work onsite in Santa Cruz as needed 

• Ability to travel up to 20% of the time with overnight stays 

• Ability to work outside the Monday–Friday, 9am–5pm schedule as needed to support cases and site activities across time zones 

Why join us:

• 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 

• We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off 

• 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!