Summary of Role
We are seeking a Clinical Project Manager to join our growing medical technology company. This individual will be responsible for driving the execution of global clinical trials with cross-functional team participation in support of our business objectives for product development and/or regulatory approvals. The ideal candidate will have excellent people skills and a can-do attitude as well as a passion for working on a cutting-edge, life-saving product.
- Execution of the clinical trial to the Clinical Plan, including managing the schedule, resources, budget and deliverables
- Assist in the creation and review of study-related planning documents: Data Management Plans, Clinical Monitoring Plans, Statistical Analysis Plans, Clinical Schedule; oversee their execution to plan.
- Participate in the clinical site selection process, Site Qualification and Site Initiation Visits.
- Monitor / co-monitor as needed
- Develop and maintain positive relationships both internal and external to project, including site personnel.
- Identify and manage risks that could derail the project, including risks related to device, subject population/recruitment.
- Provide support to team members and promote teamwork
- Participate in and/or complete other activities as assigned
- Bachelor’s degree in nursing, life science, biomedical engineering, or related field preferred
- Minimum 7 years’ experience in clinical research the medical device industry, including experience with implantable medical devices
- Familiarity with European Medical Device Directive, FDA IDE and PMA regulations
- Thorough understanding of ISO 14155
- Demonstrated project management skills
- Strong writing skills
- Familiar with software databases: Electronic Data Capture systems, MS Office
- Experience in cardiology preferred