Summary of Role
We are seeking a Senior Clinical Project Manager to join our growing Clinical team. This individual will be responsible for driving the execution of the US IDE clinical trial for our flagship product, with cross-functional team participation in support of our business objectives for product development and/or regulatory approvals. The ideal candidate will have experience with IDE studies of Class III medical devices, excellent people skills, the ability to thrive in a fast-paced environment, and a can-do attitude.
- Execution of the clinical trial to plan, including managing the schedule, resources, budget and deliverables
- Identify and manage risks that could derail the project, including risks related to device, subject population/recruitment.
- Create and/or review study-related planning documents: Data Management Plans, Clinical Monitoring Plans, Statistical Analysis Plans, Enrollment Plan, Clinical Schedule; oversee their execution to plan.
- With input from the Sr Director, be the point person for the Site Qualification and Site Initiation Visits.
- Working closely with the regionally-based field personnel, ensure enrollment timelines are met, partner with field personnel to resolve barriers to enrollment as needed
- Monitor / co-monitor as needed
- Develop and maintain positive relationships both internal and external to project, including site personnel.
- Mentor junior team members; foster a collaborative and inclusive team environment.
- Participate in and/or complete other activities as assigned
- Bachelor’s degree in nursing, life science, biomedical engineering, or related field preferred
- Minimum 10 years experience in clinical project management in the medical device industry, including experience with Class III medical devices
- Thorough understanding of FDA IDE and PMA regulations
- Demonstrated project management skills
- Strong writing skills
- Familiar with software databases: Electronic Data Capture systems, MS Office
- Experience in cardiology preferred
- Ability to travel as study needs dictate (more frequently during the planning phases)