Director of Clinical Operations, Medical Devices (IDE Trials)

Custom Search Inc.; Minneapolis (MN); On-site; USD 190,000 - 230,000; Full time

Job summary

Custom Search Inc. is seeking a Director of Clinical Affairs to lead clinical execution across two IDE studies, manage a team of five Project Managers, and strengthen operations to support FDA-ready documentation and site management.

The ideal candidate will be a hands-on clinical leader with strong cross-functional influence, capable of balancing strategic planning with daily operational leadership in a fast-paced medical device environment.

Qualifications

• 10+ years of clinical research experience in medical devices.
• 5+ years U.S. medical device clinical research, including IDEs.
• Previous people-management experience required.
• Experience at Program Manager/Director level or higher.
• Class II/III medical device experience preferred.
• Strong knowledge of GCP, FDA regulations, and clinical quality systems.
• Experience developing or improving clinical operations infrastructure.
• Experience supporting FDA audits or regulatory inspections valued.

Responsibilities

• Lead, mentor, and develop a team of five clinical Project Managers for site management and study execution.
• Drive execution across two IDE studies and ensure milestone progress.
• Lead clinical data cleanup, documentation review, and pre-audit preparation.
• Ensure programs are inspection-ready and compliant with SOPs and procedures.
• Oversee site-management activities, including site performance and issue resolution.
• Establish and maintain clinical operations SOPs, policies, and workflows.
• Support development and execution of study plans, timelines, budgets, and resources.
• Identify risks and gaps, and implement mitigating solutions.
• Partner cross-functionally with Clinical, Regulatory, Data Management, and leadership.
• Provide clear direction to the team and manage competing priorities.
• Build relationships with sites, investigators, CROs, and third-party partners.
• Oversee documentation, trial master files, safety monitoring, and reporting.
• Participate in site visits to strengthen site-management processes.

Skills

People management

Clinical study execution

Regulatory compliance

GCP knowledge

IDE studies

Cross-functional leadership

Budget planning

Site management

Education

Bachelor's degree in life sciences/engineering

Tools

CTMS

Clinical documentation systems

Job description

Custom Search Inc. is seeking a Director of Clinical Affairs to lead clinical execution across two IDE studies, manage a team of five Project Managers, and strengthen operations to support FDA-ready documentation and site management.

The ideal candidate will be a hands-on clinical leader with strong cross-functional influence, capable of balancing strategic planning with daily operational leadership in a fast-paced medical device environment.