Lead Clinical Research PM for IDE Studies (Aortic)

Artivion; Kennesaw (GA); On-site; USD 140,000 - 210,000; Full time

Job summary

Artivion, Inc. in the Atlanta metropolitan area seeks an experienced clinical research leader to manage IDE studies and oversee aortic repair technology trials. You will coordinate stakeholders, ensure regulatory compliance, and drive study execution from site operations to data analysis.

The role requires significant travel, collaboration with Regulatory, Quality, R&D and Commercial teams, and leadership of study management activities across multiple sites.

Qualifications

• Bachelor's degree required, Master's preferred.
• 10+ years in clinical research or equivalent (8+ years with advanced degree).
• Experience with aortic repair tech (surgical grafts, endovascular devices) is desirable.
• IDE studies experience is desirable.
• Medical device industry experience is desirable.
• Strong project management, critical thinking, and communication skills.
• Proficient statistical and computer skills (spreadsheet, databases, statistical analysis).
• Excellent written and oral communication skills.
• Good knowledge of medical terminology.
• Willingness to travel.

Responsibilities

• Serve as primary owner of clinical studies, overseeing all activities, timelines, budget and issue resolution.
• Lead cross-functional study team meetings and coordinate with internal/external partners.
• Manage study vendors: qualification, onboarding, contracting, budgeting, invoicing and escalation.
• Develop clinical strategy for IDE studies.
• Collaborate with Regulatory, Quality, R&D and Commercial teams.
• Oversee site operations at clinical sites ensuring compliance with protocols and regulations.
• Develop and maintain clinical documentation (protocols, case report forms, SOPs).
• Plan and support quality initiatives for data readiness and analyses.
• Assist in abstracts, manuscripts and scientific presentations with investigators.

Skills

Project management

Critical thinking

Communication skills

Statistical analysis

Education

Bachelor's degree

Master's degree (preferred)

Tools

Spreadsheet

Relational databases

Statistical analysis software

Job description

Artivion, Inc. in the Atlanta metropolitan area seeks an experienced clinical research leader to manage IDE studies and oversee aortic repair technology trials. You will coordinate stakeholders, ensure regulatory compliance, and drive study execution from site operations to data analysis.

The role requires significant travel, collaboration with Regulatory, Quality, R&D and Commercial teams, and leadership of study management activities across multiple sites.