Monitoring Oversight Lead

Job not on LinkedIn

🔥 12 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Artivion, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1984

🏥 Healthcare

🏭 Manufacturing

💼 Consulting

Healthcare • Manufacturing • Consulting

Artivion, Inc. is a medical technology company focused on developing, manufacturing, and commercializing aortic- and cardiac-centric surgical devices and biomaterial products. The company produces heart valves (On-X), aortic arch and thoracoabdominal stent graft systems, hybrid prostheses (AMDS), cryopreserved allografts and tissues, surgical adhesives (BioGlue), and ancillary vascular and cardiac surgical tools. Artivion works with cardiac and vascular surgeons and conducts clinical trials and regulatory submissions to advance device safety and efficacy, serving hospitals and surgical centers globally.

📋 Description

• Lead CRA I–IV teams at study and/or operational line-management level • Serve as Study Specific Lead CRA and/or Line Manager Lead CRA • Lead planning, execution, and management of complex clinical trials • Oversee site management activities, including data entry, query resolution, eligibility reviews, compliance, and study deadlines • Manage site visit needs, planning, report review and approvals • Train CRAs and new team members • Conduct risk assessments and ensure regulatory and industry-standard compliance • Manage third-party vendors, including CROs, flying study nurses, and site coordinators • Recruit, mentor, coach, onboard, guide, and support junior CRAs • Oversee CRA performance, professional development, resource allocation, workload management, and performance evaluations • Conduct monitoring visits according to study monitoring plans • Build and maintain relationships with investigators and site staff • Communicate visit findings and prepare monitoring visit reports and correspondence • Develop subject tracking systems, monitoring plans, corrective and preventive action plans, and trend reports • Identify potential research sites and perform study start-up activities • Train sites on data collection and safety-event reporting • Conduct study initiation visits and support site selection and training • Manage site activities, study milestones, patient safety reviews, clinical data safety/efficacy reviews, and study closeout • Participate in audits, inspections, quality assurance, CAPA execution, investigator meetings, and process improvements • Collaborate with Data Management, Project Management, Medical Writing, Clinical Affairs, and senior management

🎯 Requirements

• In-depth experience in clinical research monitoring, typically gained over 8 or more years • Ability to work independently without supervision of daily CRA activities • Ability to manage 10–15 study sites (class 2–3 products) from start-up to closure • Knowledge of all regulations and guidelines pertaining to the conduct of clinical trials on human subjects • Experience with clinical trial monitoring and site management • Knowledge of ISO 14155, GCP, MDR, EU, FDA, IRB/EC, and local regulations • Ability to perform monitoring visits and manage investigator sites • Ability to travel up to 40%

🏖️ Benefits

• Travel required, up to 40% • Equal Opportunity Employer

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