Clinical Project 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

Clinical Project Manager (CPM) is key to the success of the overall conduct of a clinical trial from planning to final report. CPM will assist in all areas of conducting a clinical research program and maybe responsible for the conduct of specific aspects of a clinical program including but not limited to: developing the clinical trial strategy, timelines, forecasting, managing the overall study budget, developing risk management / contingency plans for minimizing impact on project objectives, site selection and management, monitoring, coordination of clinical data management, data analysis functions, and CRO and Vendor selection and management.

Position Requirements:

• Knowledge Skills and Abilities
• Knowledgeable in all facets of clinical operations including ICH / GCP, 21CFR 50/54/56/812/814 for the conduct of clinical research studies.
• Demonstrated ability to persuasively influence external medical professionals to ensure project deliverables are completed on time and within budget.
• Effective analytical and problem-solving skills.
• Demonstrated project management skills across various aspects of clinical research project.
• Ability to work in a highly matrixed team environment.
• Ability to adapt to changing priorities.
• Proficiency with Microsoft Suite (e.g. Outlook, Project, Visio, Excel, Word etc.) and various data management systems / EDC systems.
• Demonstrated successful site management and monitoring.
• Ability to travel consistent with project needs.
• Bachelor’s degree in a clinical or scientific discipline and minimum of 5 years’ clinical research experience; or equivalent combination of education, training and work experience.
• Must have at least 2 years of clinical trial / clinical research site management, monitoring and project management / lead experience.
• Medical device industry experience strongly preferred.
• Direct experience with site and / or sponsor level audits or FDA BIMO investigation(s) preferred.