Principal Clinical Research PM

Artivion, Inc.; Kennesaw (GA); On-site; USD 120,000 - 180,000; Full time

Job summary

Artivion, Inc. in Georgia is seeking a seasoned Clinical Research leader to oversee IDE studies and aortic arch repair programs. You will manage studies from start to finish, coordinating stakeholders, timelines, budgets, and regulatory compliance.

You will lead cross-functional teams including Regulatory, Quality, R&D, and Clinical Operations, while ensuring adherence to GCP and quality standards. Willingness to travel and global collaboration are expected.

Qualifications

• Bachelor's degree required; Master’s degree preferred in a related field.
• At least 10 years in clinical research or 8+ years with advanced degree.
• Experience with aortic repair technology and IDE studies is highly desirable.
• Experience in a medical device company is highly desirable.
• Strong project management, critical thinking, and communication skills are essential.

Responsibilities

• Own and oversee clinical studies, including stakeholder communication, timelines, budget, and issue resolution.
• Lead cross-functional study team meetings and drive accountability with partners.
• Manage study vendors from qualification to onboarding and budget oversight.
• Develop clinical strategy for IDE studies and ensure regulatory alignment.
• Collaborate with Regulatory, Quality, R&D, and Commercial teams.
• Ensure trials run at sites per protocols, GCP, and regulatory requirements.

Skills

Project management

Critical thinking

Communication skills

Statistical analysis

Travel readiness

IDE studies experience

Education

Bachelor's degree

Master's degree preferred

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’s four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,600 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 Overview

Manage assigned departmental projects and tasks in principle areas of responsibility, which are identified below for aortic arch repair technologies, including execution of investigational device exemption (IDE) studies.

Responsibilities

• Serve as the primary owner of clinical studies, independently overseeing all study activities including stakeholder communication, team leadership, timeline execution, budget management, and issue resolution.
• Act as the main point of contact for assigned studies, leading cross-functional study team meetings and driving accountability across internal and external partners.
• Manage all study vendors, including qualification, onboarding, contract and budget oversight, invoicing, and escalation of operational issues.
• Develop clinical strategy for investigational device exemption (IDE) studies.
• Participate as a core team member, specifically collaborating with Regulatory, Quality, R&D, and Commercial stakeholders.
• Oversee day-to-day site operations at clinical sites to ensure clinical trials are conducted in compliance with protocols, contracts, GCP, and applicable regulatory requirements.
• Lead the development, review, and maintenance of clinical documentation, including protocols, study management plans, informed consent forms, case report forms, SOPs, and study amendments.
• Manage qualification, selection, and operations of study steering and safety committees.
• Plan and support quality initiatives to ensure study readiness for data analyses.
• Support the development of abstracts, manuscripts, and scientific presentations by coordinating with investigators and co-authors.
• Ensure timely preparation and completion of clinical study reports in alignment with regulatory and organizational deadlines.
• Develop and deliver study-related presentations for internal and external audiences.
• Interface with technical representatives, regional managers, and research teams to provide technical training and address clinical or customer-related inquiries.
• Facilitate regulatory submissions, including annual FDA reports and other required regulatory documentation.
• Serve as a reviewer for technical and marketing materials to ensure scientific accuracy and regulatory compliance.
• Collaborate with Quality and Risk Management partners to proactively identify, assess, and mitigate device risks.
• Support site recruitment and selection activities, investigator meetings, and site training initiatives.
• Perform basic statistical analyses to support product lines and clinical decision-making.
• Conduct literature reviews and prepare scientific summaries relevant to product development and clinical strategy.
• Attend national and international surgical and scientific congresses, in person or remotely, as required.
• Perform additional responsibilities, including duties executed at a level above current title, as assigned.

Qualifications

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