Remote Associate Director, Clinical Ops - Medical Devices

Pragmatic; South Carolina; Remote; USD 100,000 - 130,000; Full time

Benefits offered by this job

Annual bonus

Remote role with travel expenses reimb

401(k) with company match

Career pathway to senior leadership

Job summary

IDE Medical Device Trials is seeking an Associate Director of Clinical Operations to lead its CRC teams across multiple sites, reporting to the VP of Clinical Operations. This hands-on leadership role oversees start-up through close-out of IDE vascular and specialty device studies, with remote work on East Coast and ~50% travel.

You'll mentor CRCs, collaborate with investigators, ensure compliance with GCP and 21 CFR 812, manage enrollment and site performance, and drive study timelines and

Qualifications

• IDE medical device clinical trials experience is required.
• 2+ years in people leadership (CRC/CRA or site research team).
• 5+ years in clinical research, site-side, sponsor or CRO.
• Strong knowledge of GCP and FDA device regulations.
• Able to travel ~50% and work remotely.

Responsibilities

• Lead and develop Clinical Research Coordinators across multiple sites.
• Oversee site operations for IDE medical device studies: start-up, enrollment, monitoring, close-out.
• Collaborate with Principal Investigators and physicians on enrollment and site performance.
• Escalate issues to sponsors when needed.
• Monitor enrollment, budgets, contracts, and feasibility for new studies.
• Ensure adherence to GCP and IDE regulations (21 CFR 812).
• Travel to sites ~50% and provide on-site support as needed.

Skills

Leadership of CRC teams

GCP knowledge

FDA device regulations knowledge

Budgeting and contracts

Stakeholder management

Mentoring and coaching

Job description

IDE Medical Device Trials is seeking an Associate Director of Clinical Operations to lead its CRC teams across multiple sites, reporting to the VP of Clinical Operations. This hands-on leadership role oversees start-up through close-out of IDE vascular and specialty device studies, with remote work on East Coast and ~50% travel.

You'll mentor CRCs, collaborate with investigators, ensure compliance with GCP and 21 CFR 812, manage enrollment and site performance, and drive study timelines and