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Clinical Applications Analyst/Planner & Coordinator
- United States
- United States
Über
Based in Santa Cruz, our unique workspace blends cutting-edge Bay Area innovation with a lifestyle-driven environment near trails, beaches, and open space-creating the perfect place to do meaningful, career-defining work.
Description:
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. >
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! >
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Sprachkenntnisse
- English
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