Clinical Research Monitoring Lead

Terumo Cardiovascular Group; New Jersey; On-site; USD 109,000 - 152,000; Full time

Benefits offered by this job

Annual bonus

Paid vacation

Health benefits

401(k) with matching

Job summary

Terumo Aortic is seeking a Manager, Clinical Research Monitoring to lead a team of CRAs and CRCs within Clinical Operations. The role focuses on timely, budget-conscious trials that comply with FDA, GCP, and regulatory standards.

You will mentor staff, optimize monitoring strategies, and collaborate with CPGMs and CPMs to ensure high-quality deliverables. Strong leadership and GM oversight are essential for success in this matrixed environment.

Qualifications

• Bachelor's degree in life sciences, nursing, or related field is required.
• Minimum 6 years clinical research experience, including site monitoring.
• Minimum 2 years of people management experience; medical device experience preferred.

Responsibilities

• Lead, coach, and mentor a team of CRAs and CRCs to drive accountability and growth.
• Oversee site monitoring to ensure compliance with SOPs, protocols, and regulatory guidelines.
• Advise on site issues and implement corrective actions for deviations.
• Develop and manage monitoring programs in collaboration with CPGMs and CPMs.
• Coordinate with QA to prepare for audits and monitor quality risks.
• Ensure adherence to EH&S and Quality System policies and patient safety.

Skills

Team leadership

Mentoring

Project management

Regulatory compliance

Budgeting & forecasting

Critical thinking

Education

Bachelor's degree in life sciences or related field

Job description

Terumo Aortic is seeking a Manager, Clinical Research Monitoring to lead a team of CRAs and CRCs within Clinical Operations. The role focuses on timely, budget-conscious trials that comply with FDA, GCP, and regulatory standards.

You will mentor staff, optimize monitoring strategies, and collaborate with CPGMs and CPMs to ensure high-quality deliverables. Strong leadership and GM oversight are essential for success in this matrixed environment.