Senior Clinical Research Lead - IDE & Aortic Devices

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

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.