Strategic Clinical Trial Manager

Terumo Medical Corporation; New Jersey; On-site; USD 110,000 - 170,000; Full time

Job summary

Terumo Medical Corporation seeks a Clinical Project Manager to lead planning, budgeting and oversight of clinical trials. The CPM develops strategies, timelines and forecasts, coordinating data management and vendor relations to ensure trial success.

The role requires strong ICH/GCP knowledge, project leadership in a matrix environment and travel to sites as needed. Regulatory audits experience is a plus.

Qualifications

• Bachelor’s degree in a clinical or scientific discipline with at least 5 years of clinical research experience.
• At least 2 years of clinical trial/site management, monitoring and project leadership.
• Knowledge of ICH/GCP and 21CFR 50/54/56/812/814.
• Experience with site/sponsor audits or FDA BIMO preferred.
• Ability to influence external professionals to meet timelines and budgets.

Responsibilities

• Develop clinical trial strategy, timelines and forecasting.
• Manage overall study budget with risk and contingency planning.
• Oversee site selection, monitoring, and data management coordination.
• Coordinate CRO and vendor selection and management.
• Travel as required to trial sites.

Skills

ICH / GCP knowledge

Project management

Analytical skills

Problem-solving

Matrixed team environment

Adaptability

MS Office / EDC systems

Site management & monitoring

Budget forecasting

Audits / FDA BIMO experience

Education

Bachelor’s degree in a clinical or scientific discipline

Tools

MS Suite

EDC systems

Job description

Terumo Medical Corporation seeks a Clinical Project Manager to lead planning, budgeting and oversight of clinical trials. The CPM develops strategies, timelines and forecasts, coordinating data management and vendor relations to ensure trial success.

The role requires strong ICH/GCP knowledge, project leadership in a matrix environment and travel to sites as needed. Regulatory audits experience is a plus.