Manager, Clinical Research Monitoring

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At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy.

The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.

Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

The Manager, Clinical Research Monitoring (CRM) will lead a team of CRAs and Clinical Research Coordinators (CRCs), working with the broader Clinical Operations team to ensure trials are executed on time, on budget, and in full compliance with FDA, GCP, and all other regulatory requirements. The Manager, CRM will mentor CRAs, optimize monitoring strategies, and collaborate with Clinical Program Managers (CPGMs) and Clinical Project Managers (CPMs) to ensure overall quality and timeliness of clinical deliverables for studies.

Main responsibilities

• 50%:
  Lead, coach, and mentor a team of CRAs and CRCs, fostering accountability, collaboration, and professional growth.
• 15%:
  Oversee site monitoring activities to ensure compliance with study protocols, standard operating procedures (SOPs), and regulatory guidelines.
• 15%:
  Advise the team on study site issues and ensure corrective actions are taken for protocol or regulatory deviations.
• 10%:
  Develop and manage clinical study monitoring programs in collaboration with CPGMs and CPMs.
• 10%:
  Partner with Clinical Quality Assurance (CQA) to prepare for audits and inspections and monitor potential quality risks.
• Follow all established Environmental Health & Safety and Quality System policies and practices, including those concerning product and patient safety, associates, the environment, and the community.

Organizational Impact

• Guide the operational execution of clinical trials through site monitoring strategies, resource planning, and budget input.
• Help keep studies aligned with company objectives, quality standards, timelines, and financial expectations.
• Forecast CRA and CRC staffing needs based on current and anticipated studies.
• Develop clinical trial budget inputs that reflect study complexity, monitoring requirements, staffing, and site and vendor activities.
• Manage CROs and consultants, when required, to ensure contracted work is planned, monitored, and delivered.
• Partner with CPGMs and CPMs to align timelines, milestones, enrollment, monitoring activities, and operational priorities.

Communication & Influence

• Direct CRAs and CRCs on study priorities, monitoring expectations, timelines, quality requirements, and operational goals.
• Set expectations, clarify responsibilities, evaluate performance, and provide constructive feedback.
• Coordinate with CPGMs and CPMs on timelines, resources, monitoring strategy, and risk mitigation.
• Escalate issues and risks to leadership with supporting facts, impact assessments, and recommendations.
• Report monitoring metrics and key performance indicators, explaining trends and their implications for study performance.
• Analyze monitoring trends, performance data, site issues, and emerging risks to assess their impact on quality, timelines, compliance, and operations.
• Recommend actions to project teams and clinical leadership, including when an issue requires escalation or a change in strategy.
• Lead process improvements by identifying recurring problems, evaluating root causes, implementing solutions, and assessing results.
• Guide CRAs and CRCs through ambiguous site issues…