Principal Clinical Research PM

🔥 18 minutes ago

🍑 Georgia – Remote

🍑 Georgia – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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Artivion, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1984

🏥 Healthcare

🏭 Manufacturing

💼 Consulting

Healthcare • Manufacturing • Consulting

Artivion, Inc. is a medical technology company focused on developing, manufacturing, and commercializing aortic- and cardiac-centric surgical devices and biomaterial products. The company produces heart valves (On-X), aortic arch and thoracoabdominal stent graft systems, hybrid prostheses (AMDS), cryopreserved allografts and tissues, surgical adhesives (BioGlue), and ancillary vascular and cardiac surgical tools. Artivion works with cardiac and vascular surgeons and conducts clinical trials and regulatory submissions to advance device safety and efficacy, serving hospitals and surgical centers globally.

📋 Description

• Manage assigned departmental projects and tasks for aortic arch repair technologies, including execution of investigational device exemption (IDE) studies • Serve as primary owner of clinical studies, overseeing stakeholder communication, team leadership, timelines, budgets, and issue resolution • Lead cross-functional study team meetings and drive accountability across internal and external partners • Manage study vendors, including qualification, onboarding, contracts, budgets, invoicing, and operational issue escalation • Develop clinical strategy for IDE studies • Collaborate with Regulatory, Quality, R&D, and Commercial stakeholders • Oversee clinical-site operations for protocol, contract, GCP, and regulatory compliance • Lead development, review, and maintenance of clinical documentation, including protocols, study management plans, informed consent forms, case report forms, SOPs, and amendments • Manage study steering and safety committees • Plan and support quality initiatives for study readiness and data analyses • Support abstracts, manuscripts, and scientific presentations • Prepare and complete clinical study reports • Develop and deliver study-related presentations • Provide technical training and address clinical or customer-related inquiries • Facilitate regulatory submissions, including annual FDA reports • Review technical and marketing materials for scientific accuracy and regulatory compliance • Identify, assess, and mitigate device risks with Quality and Risk Management partners • Support site recruitment, investigator meetings, and site training • Perform basic statistical analyses for product lines and clinical decision-making • Conduct literature reviews and prepare scientific summaries • Attend national and international surgical and scientific congresses • Perform additional assigned responsibilities, including duties above the current title level

🎯 Requirements

• Minimum of a Bachelor’s degree; a Master’s degree in a related field is preferred • Minimum 10 years’ experience in clinical research or relevant experience, or an advanced degree with 8 years’ experience • Experience with aortic repair technology, such as surgical grafts and endovascular devices, is highly desirable • Experience working on investigational device exemption (IDE) studies is highly desirable • Experience working at a medical device company is highly desirable • Demonstrated project management, critical thinking, and communication skills • Demonstrated statistical and computer skills, including spreadsheets, relational databases, and intermediate to advanced statistical analysis • Excellent written and oral communication skills • Proficient knowledge of medical terminology • Willingness to travel

🏖️ Benefits

• Willingness to travel • Opportunity to attend national and international surgical and scientific congresses, in person or remotely, as required

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