Sr. Project Manager, Clinical Research

Terumo Neuro is seeking a Sr. Project Manager for Clinical Research to lead and manage a team of Clinical Research Associates. The role involves ensuring the successful execution of clinical trials while adhering to regulatory requirements, providing strategic guidance, and fostering operational excellence.

Responsibilities:

• Responsible for leading and managing a team of field Clinical Research Associates (CRAs) (monitors) and in-house CRAs to ensure the successful execution of clinical trials in compliance with regulatory requirements, Good Clinical Practice (GCP), and company standards
• Oversee CRA performance, provide strategic guidance, and ensure operational excellence across all phases of clinical research
• Recruit, train, mentor, and develop field and in-house CRAs to maintain a high-performing team
• Conduct regular performance evaluations and provide coaching for career development
• Foster a culture of collaboration, accountability, and continuous improvement
• Ensure sites are monitored according to protocol, SOPs, and regulatory guidelines
• Review monitoring reports and ensure timely resolution of site issues
• Oversee site selection, initiation, monitoring, and close-out activities
• Develop and manage CRA resource plans to meet project timelines and budgets
• Collaborate with cross-functional teams (e.g., Clinical Operations, Data Management, Safety, etc.) to ensure seamless trial execution
• Identify and mitigate risks impacting study deliver
• Track and report CRA performance metrics and study progress to senior leadership
• Provide input into departmental strategy and process improvements
• Ensure adherence to GCP, ICH guidelines, and applicable regulatory requirements
• Implement quality control measures to maintain data integrity and patient safety
• Support audit and inspection readiness across all assigned studies
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization
• Perform additional duties as assigned

Requirements:

• Bachelor's degree in Life Sciences or related field
• Minimum of eight (8) years of direct clinical research experience, including a minimum of four (4) years of experience supporting neurovascular clinical trials in the medical device industry
• Minimum two (2) years of personnel management experience in the medical device industry
• Demonstrated ability to lead teams in a matrix environment
• In-depth understanding of clinical study management, terminology, and related GCP and regulatory requirements
• Proven experience with audits and regulatory inspections
• Proficiency with basic study design and logistical elements such as protocol development, site selection, budget development, IRB submission preparation, training, database/CRF development, contracts, informed consent, randomization, monitoring, statistical plans, and the tracking of study metrics
• Strong verbal and written communication skills
• Proficiency in the use of MS Office products including Word, Excel, PowerPoint, Outlook, Teams, etc
• Proficiency in various clinical research eSystems including Meritive, Veeva, iMedNet, and others
• Master's degree in Business or Life Sciences, or equivalent combination of education, training, and experience
• Experience in implementing clinical trials and interpreting trial results, including an understanding of data and data analysis
• Minimum five (5) years of monitoring experience, preferably in the medical device industry
• IDE clinical experience strongly preferred, including experience in conducting global studies
• An understanding of worldwide regulations governing the conduct of clinical studies
• Ability to handle multiple tasks efficiently and consistently, meeting deadlines
• Detail-oriented
• Ability to maintain strict confidentiality