Artivion, Inc. · 2 hours ago
Clinical Research Project Manager
Kennesaw, GA
Full-time
Hybrid
Entry, Mid Level
2+ years expArtivion, Inc. is a medical device company headquartered in suburban Atlanta, Georgia, specializing in solutions for cardiac and vascular surgeons. The Clinical Research Project Manager will support global clinical trials by ensuring regulatory compliance, managing site and vendor activities, and maintaining data integrity while contributing to high-quality clinical documentation.
Biotechnology
Responsibilities
Supports regulatory submissions to competent authorities
May act as a site manager, and may provide site training
Interacts with sites in accordance with local law, standards, and regulations
Participates in vendor selection process
Works with vendor on contracts
Manages invoices
Collaborates on core clinical documents
Represents the core clinical documents and study processes to participating sites in the context of Site Regulatory Binders
Executes/supports clinical investigators with preparation and submission of required documentation to Institutional Review Boards (IRBs)/Ethics Committee (EC) for approval
Ensures maintenance of IRB/EC approval throughout the duration of the study
Provides training to clinical investigators and study personnel regarding protocol requirements, data collection and reporting requirements as necessary
Assists with developing Health Care Provider (HCP) presentations
May engage with cross functional teams
Facilitates queries for all missing or inaccurate data
Ensures that data changes are properly implemented and captured in the database or data system
Assists in the evaluation and analysis of clinical trial data
Disseminates publications to sites as necessary
Review clinical reports and conduct quality and consistency checks for regulatory submission and/or scientific publication
Learn the function and clinical applications of a surgical implant which treats complex heart disease conditions, understand the indication, safety, and performance objectives and parameters and ensure consistency across multiple clinical documents
Contribute to EU Medical Device Regulation processes and documentation generation and support submissions to Notified Bodies
Support ongoing Post-Market Surveillance and Quality Assurance activities
Ability to travel domestically and internationally up to 30% of the time
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
Experience overseeing multicenter investigational (e.g. IDE/ pre-CE) studies
Demonstrate project management, critical thinking, and communication skills
Proficient knowledge of medical terminology
Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications
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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