Artivion, Inc. · 10 hours ago
Clinical Research Project Manager
United States
Full-time
Remote
Entry, Mid Level
2+ years expArtivion, Inc. is a medical device company focused on developing solutions for cardiac and vascular surgeons. The Clinical Research Project Manager will manage project tasks related to aortic arch repair technologies, ensuring clinical trials are conducted according to standards and regulations while overseeing project timelines and budgets.
Biotechnology
Responsibilities
Liaison between Artivion, study sites, CROs, and other vendors (as applicable) to ensure study engagement and encourage transparent communication
Management of clinical study sites to ensure that clinical trials are conducted in accordance with applicable standards and regulations
Oversee project timelines, budgets, budget change forms, accruals, and monthly reports
Support the development and amendment of the following documents: clinical protocol, study management plans, informed consent forms, case report forms, SOPs, etc
Collect, query, analyze, and present clinical data and prepare internal and external study reports
Conduct basic statistical analyses for technical support of product lines
Conduct literature reviews and write research summaries related to product lines
Interface with technical representatives, regional managers, and research teams for the purpose of technical training and addressing customer questions/concerns
Communicate with customers and field staff regarding the planning of clinical trials, complaints, problems, and general correspondence
Evaluate and report on adverse events and complaints associated with the product lines
Attend surgical congresses in person or remotely, as necessary
Coordinate the execution of peer-reviewed projects (publications, posters, abstracts) and marketing literature
Support clinical strategy development for investigational device exemption (IDE) studies
Participate in site recruitment/selection, investigator meetings, and site training
Support the maintenance of any applicable clinical research databases as necessary
Support the development of product Instructions for Use and assist with labeling and labeling changes
Provide clinical support for marketing, regulatory, research and development, and quality departments
Qualification
Required
Bachelor's degree in biological science, engineering, or another science-related field
Minimum 2 years' experience planning and executing clinical research studies [or] relevant experience, or advanced degree with 1 years' experience
Demonstrate project management, critical thinking, and communication skills
Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications
Preferred
Experience overseeing multicenter investigational (e.g. IDE) studies is highly desirable
Experience with aortic disease is highly desirable
Company
Artivion, Inc.
Artivion is a leader in the manufacturing, processing, and distribution of medical devices and implantable tissues used in cardiac and vascular surgical procedures focused on aortic repair.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Pat Mackin
President & CEO
Ashley Lee
EVP, COO & CFO
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