Clinical Research Project Manager

Company Overview:

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.

Position Objective:

The Clinical Research Project Manager is responsible for the management of assigned departmental project tasks/systems identified below in support of aortic arch repair technologies.

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.

Qualifications:

• 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
• Experience overseeing multicenter investigational (e.g. IDE) studies is highly desirable.
• Experience with aortic disease is highly desirable.
• 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