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. Our purpose is to develop simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with diseases of the aorta and deliver breakthrough technologies of unsurpassed quality that have far-reaching impact. Our decades of expertise in treating aortic diseases—coupled with our recent acquisitions and partnerships—have empowered us to offer cardiac and vascular surgeons a suite of aortic-centric solutions such as cryopreserved cardiac and vascular allografts, surgical sealants, prosthetic heart valves, and aortic stents and stent-grafts. Artivion has over 1,250 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.

Clinical Research Project Manager

Clinical ResearchClinical ResearchFull TimeRemoteTeam 1,400Since 1984

Location

Georgia

Posted

33 days ago

Salary

Not specified

Bachelor Degree2 yrs expEnglishExcelMS OfficePower PointProjectWord

Job Description

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: To support the successful execution of global clinical trials by ensuring regulatory compliance, managing site and vendor activities, maintaining data integrity, and contributing to high-quality clinical documentation. This role advances the development of innovative surgical implants for complex heart disease while collaborating cross-functionally and upholding international standards for patient safety and study quality. 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. 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/ 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 Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Job Requirements

  • 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.

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